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510(k) K970814

NON-STERILE ISOLATION GOWN by American Seal Co. — Product Code FYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1997
Date Received
March 6, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by American Seal Co.

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  • K972187 — BOUFFANT CAP (September 9, 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)

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