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510(k) K791510

BLUE FIELD ENTOPTOSCOPE BFE100 by Medical Instrument Research Assoc., Inc. — Product Code HLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 1979
Date Received
August 2, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Other clearances by Medical Instrument Research Assoc., Inc.

  • K780987 — SOFT SILICONE ELASTOMER SPONGE EXPLANT (September 28, 1978)
  • K770888 — POMERANTZEFF EQUATOR PLUS CAMERA (June 3, 1977)
  • K760550 — IMPLANT, SILICONE AND TANTALUM (October 5, 1976)

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