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510(k) K920177

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

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

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  • 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)