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510(k) K822483

MULTIPLE SCRUB SUIT by Surgilite Intl., Inc. — Product Code FXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1982
Date Received
August 17, 1982
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 Surgilite Intl., Inc.

  • K823671 — NO-GAUZE LAPAROTOMY SPONGE (January 9, 1983)
  • K822482 — SURGILITE NON-WOVEN WRAP (September 21, 1982)
  • K822481 — MULTIPLE SURGICAL MASK (September 17, 1982)
  • K771531 — LAPAROTOMY SPONGES (September 6, 1977)

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)
  • K831207 — SPUNGUARD SCRUB SUIT (May 16, 1983)