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510(k) K870978

T-TUBE INSERTER by Sur-Med Instruments, Inc. — Product Code JYM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1987
Date Received
March 10, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Inserter, Myringotomy Tube
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Sur-Med Instruments, Inc.

  • K903401 — SPECIAL RONGEUR (August 10, 1990)
  • K870897 — KODNER ANAL PERIONEAL RETRACTOR (June 4, 1987)

Other clearances for product code JYM

  • K924901 — DEANS DISPOSABLE T-TUBE INSERTER (January 28, 1993)
  • K822349 — ARMSTRONG V TUBE SUCTION INSERTER (September 13, 1982)
  • K822348 — TYTAN TUBE INSERTER (September 7, 1982)