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510(k) K931607

MEDDRAINS by Armm, Inc. — Product Code GBN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1993
Date Received
April 1, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Pediatric, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Armm, Inc.

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  • K923201 — ENDOSI SUCTION IRRIGATOR (September 23, 1993)
  • K922245 — SUPER-FLOW TUBING (September 3, 1993)

Other clearances for product code GBN

  • K802783 — SURGEONS CHOICE STAPLE, REMOVE/IMPLANT (December 16, 1980)