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510(k) K923283

SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT by Savoy Medical Supply Co., Inc. — Product Code KKX

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
January 4, 1993
Date Received
July 6, 1992
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 Savoy Medical Supply Co., Inc.

  • K922133 — HOSPITAL KIT SV 105 (June 7, 1993)
  • K922130 — HOSPITAL KIT DK 117 (May 24, 1993)
  • K922127 — HOSPITAL KIT GP 103 (March 29, 1993)
  • K923281 — SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT (March 26, 1993)
  • K922128 — HOSPITAL KIT EP 104 (March 23, 1993)
  • K922126 — HOSPITAL KIT ENT 1125 (January 21, 1993)

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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)