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510(k) K781959

SURGICAL GOWNS, SHEETS by Convertors — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1979
Date Received
November 21, 1978
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 Convertors

  • K780627 — SURG-O-PAK, GOWNS, SHEETS, AND TOWELS (July 11, 1979)
  • K790234 — DRAPE PACKS, SURGICAL GOWNS (February 22, 1979)
  • K781534 — SURG-O-PAK PREP PAD (October 24, 1978)
  • K781099 — SURGICAL GOWNS AND DRAPES (August 14, 1978)
  • K780169 — MASK, SURGICAL (February 13, 1978)
  • K771929 — PEDIATRICS GOWN (November 16, 1977)
  • K770933 — BIO-SHIELD CSR WRAP (September 2, 1977)
  • K770346 — ORTHOPEDIC STOCKINETTE (March 7, 1977)
  • K761034 — SURGEX SURGICAL SPONGE (January 5, 1977)

Other clearances for product code KKX

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  • K202208 — BeneHold Surgical Incise Drape with CHG antimicrobial (July 30, 2021)
  • K200238 — ControlRad Sterile Cover (April 26, 2020)
  • K163556 — MediClear PreOp (September 14, 2017)
  • K133080 — Plus Surgical Drapes (EO Sterilized), PMDB-XXX (June 24, 2015)
  • K141324 — HONGYU DISPOSABLE SURGICAL DRAPES (April 14, 2015)
  • K140195 — SURGICAL DRAPE (September 10, 2014)
  • K140330 — 3M STERI-DRAPE FABRIC SURGICAL DRAPES (August 18, 2014)
  • K141438 — WHITNEY MEDICAL SOLUTIONS ESHIELD (August 14, 2014)