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510(k) K780987

SOFT SILICONE ELASTOMER SPONGE EXPLANT by Medical Instrument Research Assoc., Inc. — Product Code HOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1978
Date Received
June 14, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sponge, Ophthalmic
Device Class
Class II
Regulation Number
886.4790
Review Panel
OP
Submission Type

Other clearances by Medical Instrument Research Assoc., Inc.

  • K791510 — BLUE FIELD ENTOPTOSCOPE BFE100 (December 11, 1979)
  • K770888 — POMERANTZEFF EQUATOR PLUS CAMERA (June 3, 1977)
  • K760550 — IMPLANT, SILICONE AND TANTALUM (October 5, 1976)

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