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510(k) K831207

SPUNGUARD SCRUB SUIT by Kimberly-Clark Corp. — Product Code FXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 1983
Date Received
April 12, 1983
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

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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)
  • K865022 — SURGICAL GARMENTS (January 12, 1987)
  • K822483 — MULTIPLE SCRUB SUIT (September 17, 1982)