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510(k) K890565

GELLHORN PESSARY 33410 VARIOUS SIZES by Medi-Source, Inc. — Product Code HHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1989
Date Received
February 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pessary, Vaginal
Device Class
Class II
Regulation Number
884.3575
Review Panel
OB
Submission Type

Other clearances by Medi-Source, Inc.

  • K903402 — GEOHESIVE (TM), MODEL NUMBERS 1022L, 1023L, 1026L (August 22, 1990)
  • K890566 — BERMAN TYPE AIRWAY #59422-59429 VARIOUS SIZES (March 15, 1989)
  • K890567 — BITE BLOCK #59430 (February 17, 1989)

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