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510(k) K972187

BOUFFANT CAP by American Seal Co. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1997
Date Received
June 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Surgical
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances by American Seal Co.

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  • 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)

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