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510(k) K882282

SUIT, SURGICAL by A Plus International, Inc. — Product Code FXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1988
Date Received
May 31, 1988
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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  • K031353 — SOLUTION FACE MASKS (June 19, 2003)
  • K882280 — COVER, SHOE OPERATING ROOM (June 23, 1988)
  • K882281 — GOWN, ISOLATION, SURGICAL (FYC) (June 23, 1988)
  • K882283 — BOUFFANT CAP (June 23, 1988)
  • K882284 — SURGEONS CAP (June 23, 1988)
  • K881396 — OPERATING ROOM TOWELS -STERILE & NON-STERILE (April 29, 1988)
  • K881395 — GAUZE AND LAP SPONGES -STERILE & NON-STERILE (April 28, 1988)

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)
  • K865022 — SURGICAL GARMENTS (January 12, 1987)
  • K831207 — SPUNGUARD SCRUB SUIT (May 16, 1983)
  • K822483 — MULTIPLE SCRUB SUIT (September 17, 1982)