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510(k) K821313

SURGICAL UTILITY DRAPE by Megaplast, Inc. — Product Code FJZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1982
Date Received
May 4, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Declotting Tray, Kit (Including Contents)
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances by Megaplast, Inc.

  • K822158 — OPEN HEART TRAY (CUSTOM DESIGNED) (October 13, 1982)
  • K820423 — SUTURE REMOVAL TRAY (March 10, 1982)
  • K820136 — URINARY DRAINAGE BAG (January 29, 1982)
  • K810250 — TRAY, IRRIGATION (April 7, 1981)
  • K810249 — TRAY, CATHERIZATION, URETHRAL (April 7, 1981)
  • K810251 — SYRINGE, ENT (March 11, 1981)

Other clearances for product code FJZ

  • K821666 — STERILE SURGICAL DRAPES (June 21, 1982)
  • K760995 — DECOLLATING TRAY (January 6, 1977)