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510(k) K821245

DESERET OFFSET PRN ADAPTER by Warner-Lambert Co. — Product Code KGZ

K821245 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "DESERET OFFSET PRN ADAPTER". The FDA issued a decision of Substantially Equivalent on May 13, 1982. The device falls under product code KGZ (Accessories, Catheter), a Class I device regulated under 21 CFR 878.4200. Warner-Lambert Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1982
Date Received
April 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Warner-Lambert Co.

  • K024160 — NEOSPORIN SCAR SOLUTION (March 17, 2003)
  • K893452 — EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM (June 22, 1989)
  • K870584 — O.P.T.(TM) OVULATION PREDICTION TEST (November 25, 1987)
  • K861510 — MULTILUMEN VIAPIC CENTRAL LINE CATHETER (June 9, 1986)
  • K852967 — GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK (August 19, 1985)
  • K852689 — GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK (August 19, 1985)
  • K852843 — GENERAL DIAGNOSTICS COAG-A-MATE XC (August 13, 1985)
  • K852889 — GENERAL DIAGNOSTICS RAPID E. COLI TEST (July 23, 1985)
  • K850411 — GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY (May 8, 1985)
  • K850409 — GEN. DIAG. CHROMOSTRATE REF. PLASMA (May 8, 1985)

Other clearances for product code KGZ

  • K022306 — AART SILICONE TUBING (October 10, 2002)
  • K974295 — BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING (February 10, 1998)
  • K973183 — WOUND DRAINAGE HOLDER (January 23, 1998)
  • K955433 — DURALASTIC SILICONE TUBING (January 26, 1996)
  • K942315 — NAVARRE PERCUTANEOUS ACCESS SET (July 8, 1994)
  • K896087 — PALESTRANT IRRIGATION AND DRAINAGE SET (November 3, 1989)
  • K895041 — OPTICAL CATHETER(TM) INTRODUCER SETS (October 16, 1989)
  • K893406 — DESERET PRN ADAPTER (June 22, 1989)
  • K873009 — CONCEPT SWITCHING STICK (August 17, 1987)
  • K870014 — HCI GENERAL PURPOSE CATHETER STYLET (February 6, 1987)

FDA data resources