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510(k) K810291

STERILE/DISPOSABLE HSG TRAY by Unimar, Inc. — Product Code EYY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1981
Date Received
February 3, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Urological, Disposable
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by Unimar, Inc.

  • K932432 — KRONNER REINFORCING STYLETTE (April 12, 1994)
  • K920803 — HSG TRAY (October 19, 1992)
  • K910317 — UNI-SEM(TM) (May 1, 1991)
  • K904473 — KRONNER MANIPUJECTOR (December 14, 1990)
  • K895659 — HUI MINI-FLEX (December 19, 1989)
  • K895403 — ASPIRETTE ENDOCERVICAL ASPIRATOR (November 29, 1989)
  • K894264 — KDF-2.3 (August 15, 1989)
  • K890848 — CERVEX-BRUSH (May 11, 1989)
  • K854415 — ENDOMETRIAL PIPELLE (March 13, 1986)

Other clearances for product code EYY

  • K851675 — THE PERCUTANEOUS NEPHROSTOLITHOTOMY DRAPE (May 14, 1985)