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510(k) K931144

STERILE SURGEON'S GOWN, MODIFICATION by Amsco Sterile Recoveries, Inc. — Product Code FYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1994
Date Received
March 5, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gown, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Amsco Sterile Recoveries, Inc.

  • K932522 — AMSCO STERILE RECOVERIES SURGICAL PACKS (September 9, 1994)
  • K931143 — AMSCO STERILE RECOVERIES ABSORBENT TOWELS (September 8, 1994)
  • K931146 — SURGICAL DRAPES, MODIFICATION (June 13, 1994)
  • K931874 — RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE (June 10, 1994)
  • K931875 — AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE (June 10, 1994)
  • K931145 — NON-STERILE ISOLATION GOWN (June 10, 1994)
  • K932035 — NON-LINTING DELIVERY BLANKET (May 26, 1994)
  • K925815 — REUSABLE LIQUIDPROOF BOOTIE (July 9, 1993)
  • K921049 — SURGICAL DRAPE (October 1, 1992)
  • K920405 — STERILE SURGEON'S GOWN (August 18, 1992)

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