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510(k) K940228

BOUFFANT CAP by Derekduck Industries Corp. — Product Code LYU

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1994
Date Received
January 14, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Surgical Apparel
Device Class
Class I
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Derekduck Industries Corp.

  • K942351 — DI ISOLATION GOWN (May 17, 1995)
  • K940226 — SHOE COVER (September 26, 1994)

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  • K964364 — DISPOSABLE APRON (February 25, 1997)
  • K961791 — DEPUY DISPOSABLE FILTER/HOOD (August 9, 1996)
  • K961454 — AMMI MAGNI-GUARD (July 25, 1996)
  • K945302 — SLOAN STA-DRI PANT PROTECTOR (March 19, 1996)
  • K954314 — ULTRAFIT LINERS (December 28, 1995)
  • K953089 — I-SPOUSE (October 16, 1995)
  • K952303 — SPLASH ASSIST (August 24, 1995)