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510(k) K830675

ORAL SPONGE by Unisplint Corp. — Product Code GEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1983
Date Received
March 3, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
File, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Unisplint Corp.

  • K820944 — DENTAL ARCH BAR (May 5, 1982)

Other clearances for product code GEO

  • K844145 — GENERAL SURGICAL FILES (November 20, 1984)