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510(k) K891212

APRONS, SCRUBS SLACKS & TOPS, PATIENT DRAPE by Pro-Safe Professional Linens, Inc. — Product Code FXO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1989
Date Received
March 7, 1989
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 Pro-Safe Professional Linens, Inc.

  • K891210 — POCKETED WRAPS #3009 A,B,C (October 13, 1989)
  • K891216 — DENTAL EQUIPMENT PROTECTION DEVICES (June 2, 1989)
  • K891214 — DENTAL SURGICAL WRAP #3007 A,B,C (April 14, 1989)
  • K891215 — FAST WRAP #M 101 (April 14, 1989)
  • K891211 — SURGICAL GOWN #2001 (April 14, 1989)
  • K891213 — SURGICAL INSTRUMENT POUCH #M102 (April 14, 1989)

Other clearances for product code FXO

  • K914615 — BTP(TM) CENTRALINE(TM) SUIT (May 5, 1992)
  • K882282 — SUIT, SURGICAL (June 23, 1988)
  • K865022 — SURGICAL GARMENTS (January 12, 1987)
  • K831207 — SPUNGUARD SCRUB SUIT (May 16, 1983)
  • K822483 — MULTIPLE SCRUB SUIT (September 17, 1982)