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510(k) K920177

VERSA-VIAL by Bioteque America, Inc. — Product Code DQF

K920177 is an FDA 510(k) premarket notification submitted by Bioteque America, Inc. for the device "VERSA-VIAL". The FDA issued a decision of Substantially Equivalent on July 13, 1992. The device falls under product code DQF (Actuator, Syringe, Injector Type), a Class II device regulated under 21 CFR 870.1670. Bioteque America, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1992
Date Received
January 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Actuator, Syringe, Injector Type
Device Class
Class II
Regulation Number
870.1670
Review Panel
HO
Submission Type

Other clearances by Bioteque America, Inc.

  • K041094 — HSG CATHETER SET (June 17, 2004)
  • K020628 — CURELLE, PREFERRED CURELLE, CUTEQ 2.5 (May 24, 2002)
  • K013289 — BIOTEQUE VAGINAL PESSARIES (December 27, 2001)
  • K003380 — BIOTEQUE VAGINAL DILATOR (January 29, 2001)
  • K920633 — PESSARY FLEXIBLE SILICONE NICHOLS (November 8, 1995)
  • K920747 — PESSARY FLEXIBLE SILICONE DONUT RING (August 29, 1994)
  • K933628 — CYTOLOGY BRUSH (March 11, 1994)
  • K933521 — SPECULUM (March 7, 1994)
  • K920187 — FLEXIBLE SILICONE GELIHORN (October 23, 1992)

Other clearances for product code DQF

  • K882723 — ALCON FLUID INJECTOR (November 8, 1988)
  • K880740 — MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE (March 22, 1988)

FDA data resources