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510(k) K935669

SYRIGENE PRE-FILLED SYRINGE by Regulatory & Marketing Services, Inc. — Product Code JDL

K935669 is an FDA 510(k) premarket notification submitted by Regulatory & Marketing Services, Inc. for the device "SYRIGENE PRE-FILLED SYRINGE". The FDA issued a decision of Substantially Equivalent on February 18, 1994. The device falls under product code JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3320. Regulatory & Marketing Services, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1994
Date Received
November 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
Device Class
Class III
Regulation Number
888.3320
Review Panel
OR
Submission Type

Other clearances by Regulatory & Marketing Services, Inc.

  • K101721 — WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA (March 24, 2011)
  • K944673 — MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE (April 10, 1996)
  • K954752 — PEDIATRIC EUROPHYLIC FOLEY CATHETER (October 30, 1995)
  • K941342 — PAIN DOC (October 13, 1995)
  • K941543 — DIAL MEDICAL KIT (February 16, 1995)
  • K944379 — ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG (February 15, 1995)
  • K944384 — ORION'S URETHRAL CATHETERIZATION KIT WITHOUT BAG (February 15, 1995)
  • K944378 — ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG (February 15, 1995)
  • K945874 — EUROMEDICAL POLY TRACHEOTOMY TUBE (December 27, 1994)
  • K944382 — ORION ALL SILICONE FOLEY CATHETER (December 6, 1994)

Other clearances for product code JDL

  • K073499 — VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES (August 7, 2008)
  • K070785 — DYNASTY ACETABULAR SYSTEM (July 11, 2007)
  • K061844 — DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER (December 6, 2006)
  • K051995 — PROFEMUR RENAISSANCE HIP STEM (August 22, 2005)
  • K051348 — CONSERVE TOTAL FEMORAL HEAD (August 19, 2005)
  • K042841 — M2A/C2A ACETABULAR SYSTEM (December 21, 2004)
  • K041586 — PROFEMUR S HIP STEM (July 9, 2004)
  • K041114 — PROFEMUR TAPERED HIP STEM (May 28, 2004)
  • K004043 — METAL TRANSCEND ARTICULATION SYSTEM (July 13, 2001)
  • K950542 — METAL BACKED ACETABULAR COMPONENT (May 25, 1995)

FDA data resources