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510(k) K770888

POMERANTZEFF EQUATOR PLUS CAMERA by Medical Instrument Research Assoc., Inc. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1977
Date Received
May 16, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

Other clearances by Medical Instrument Research Assoc., Inc.

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  • K780987 — SOFT SILICONE ELASTOMER SPONGE EXPLANT (September 28, 1978)
  • K760550 — IMPLANT, SILICONE AND TANTALUM (October 5, 1976)

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