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510(k) K851675

THE PERCUTANEOUS NEPHROSTOLITHOTOMY DRAPE by Lingeman Medical Products, Inc. — Product Code EYY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1985
Date Received
April 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drape, Urological, Disposable
Device Class
Class II
Regulation Number
878.4370
Review Panel
HO
Submission Type

Other clearances for product code EYY

  • K810291 — STERILE/DISPOSABLE HSG TRAY (March 18, 1981)