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510(k) K865022

SURGICAL GARMENTS by Ulti-Med Intl., Inc. — Product Code FXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1987
Date Received
December 23, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suit, Surgical
Device Class
Class I
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Ulti-Med Intl., Inc.

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  • K923175 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K923176 — SURGICAL INSTRUMENT KIT, DISPOSABLE (June 17, 1993)
  • K920989 — SURGICAL INSTRUMENT KIT, DISPOSABLE (October 19, 1992)
  • K922828 — ULCER WOUND TRAY (September 28, 1992)
  • K914244 — STERILE CUSTOM SURGICAL KITS (February 24, 1992)
  • K914431 — ABSORBENT FIBER (December 4, 1991)
  • K912693 — POST OPERATIVE SPONGE (October 4, 1991)
  • K912692 — CONFORMING BANDAGE (October 4, 1991)
  • K904896 — EYE PAD (December 5, 1990)

Other clearances for product code FXO

  • K914615 — BTP(TM) CENTRALINE(TM) SUIT (May 5, 1992)
  • K891212 — APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE (April 14, 1989)
  • K882282 — SUIT, SURGICAL (June 23, 1988)
  • K831207 — SPUNGUARD SCRUB SUIT (May 16, 1983)
  • K822483 — MULTIPLE SCRUB SUIT (September 17, 1982)