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510(k) K820078

DRAPE, SURGICAL by James L. Geraci & Associates, Inc. — Product Code KKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1982
Date Received
January 12, 1982
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 James L. Geraci & Associates, Inc.

  • K853927 — LASE SYSTEM II (October 16, 1985)
  • K820091 — AIRMED SMOKE EVACUATION & FILTER (February 24, 1982)
  • K820079 — AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL (February 5, 1982)
  • K811698 — CARL ZEISS INN MYRINGOTOMY TUBE LINE (August 31, 1981)

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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)