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510(k) K972227

SHOE COVER by American Seal Co. — Product Code FYF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1997
Date Received
June 13, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cap, Surgical
Device Class
Class I
Regulation Number
878.4040
Review Panel
SU
Submission Type

Other clearances by American Seal Co.

  • K972187 — BOUFFANT CAP (September 9, 1997)
  • K970814 — NON-STERILE ISOLATION GOWN (May 27, 1997)
  • K964358 — AMSEAL SURGICAL FACE MASK (February 14, 1997)
  • K892557 — MAYTEX NON-STERILE LATEX EXAM GLOVE (May 31, 1989)
  • K892553 — MAYTEX PATIENT EXAMINATION GLOVES (May 25, 1989)

Other clearances for product code FYF

  • K955833 — NIOMED SURGICAL CAPS (March 15, 1996)
  • K954556 — SURGICAL CAP (March 12, 1996)
  • K954455 — NIOMED BOUFFANT CAPS (January 23, 1996)
  • K954454 — NIOMED SURGICAL HOOD (January 23, 1996)
  • K953879 — SURGEON'S CAP (January 5, 1996)
  • K953878 — BOUFFANT CAP (January 5, 1996)
  • K913700 — DISPOSABLE BOUFFANT CAP (October 4, 1991)
  • K882346 — INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD (June 30, 1988)
  • K882283 — BOUFFANT CAP (June 23, 1988)
  • K882284 — SURGEONS CAP (June 23, 1988)