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510(k) K954903

PEDI VAGINAL ASPIRATOR by Cook Urological, Inc. — Product Code HFC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1996
Date Received
October 25, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aspirator, Endocervical
Device Class
Class II
Regulation Number
884.1050
Review Panel
OB
Submission Type

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Other clearances for product code HFC

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  • K960263 — CERVICAL MUCOUS ASPIRATION CATHETER (August 29, 1996)
  • K954102 — SELECTMUCUS (November 21, 1995)
  • K902242 — ENDOCERVICAL ASPIRATOR (October 9, 1990)
  • K902032 — O. B. PACK IV (September 28, 1990)
  • K902954 — OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) (August 23, 1990)
  • K895403 — ASPIRETTE ENDOCERVICAL ASPIRATOR (November 29, 1989)
  • K821134 — DC PACK TM (June 22, 1982)
  • K812175 — ENDOCERVICAL ASPIRATOR (September 21, 1981)
  • K801238 — ACCU-PAP T ZONE SAMPLER (August 12, 1980)