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510(k) K903002

PROBET (TM) by Gynopharma, Inc. — Product Code HFF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1991
Date Received
July 9, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aspirator, Endometrial
Device Class
Class II
Regulation Number
884.1060
Review Panel
OB
Submission Type

Other clearances by Gynopharma, Inc.

  • K903001 — SLIMCATH (TM) (June 25, 1991)

Other clearances for product code HFF

  • K041237 — ECHOSAMPLER (September 8, 2004)
  • K902693 — WALLACH FLEXIBLE ENDOMETRIAL SAMPLER (January 31, 1991)
  • K831212 — ENDOSCANN (June 15, 1984)
  • K820641 — ACCURETTE (June 22, 1982)