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510(k) K831952

SURGICAL APPAREL SHOE COVERS by Sudreca Surgical Dressings, Inc. — Product Code BWP

K831952 is an FDA 510(k) premarket notification submitted by Sudreca Surgical Dressings, Inc. for the device "SURGICAL APPAREL SHOE COVERS". The FDA issued a decision of Substantially Equivalent on July 12, 1983. The device falls under product code BWP (Shoe And Shoe Cover, Conductive), a Class I device regulated under 21 CFR 878.4040. Sudreca Surgical Dressings, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1983
Date Received
June 15, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shoe And Shoe Cover, Conductive
Device Class
Class I
Regulation Number
878.4040
Review Panel
SU
Submission Type

Other clearances by Sudreca Surgical Dressings, Inc.

  • K832173 — GAUZE SPONGE STERILE (August 12, 1983)
  • K832172 — GAUZE SPONGE X-RAY DETECTABLE- (August 12, 1983)
  • K832174 — GAUZE SPONGE NON-STERILE (August 12, 1983)

Other clearances for product code BWP

  • K880384 — KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOT (June 23, 1988)
  • K812105 — ANOGO DISPOSABLE SHOE COVER (September 11, 1981)

FDA data resources