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510(k) K760550

IMPLANT, SILICONE AND TANTALUM by Medical Instrument Research Assoc., Inc. — Product Code HQJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1976
Date Received
August 30, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Absorbable, (Scleral Buckling Methods)
Device Class
Class II
Regulation Number
886.3300
Review Panel
OP
Submission Type

Other clearances by Medical Instrument Research Assoc., Inc.

  • K791510 — BLUE FIELD ENTOPTOSCOPE BFE100 (December 11, 1979)
  • K780987 — SOFT SILICONE ELASTOMER SPONGE EXPLANT (September 28, 1978)
  • K770888 — POMERANTZEFF EQUATOR PLUS CAMERA (June 3, 1977)

Other clearances for product code HQJ

  • K896350 — TITAN AIR SPECTACLE FRAME (December 18, 1989)
  • K884362 — LABELING CHANGES TO FYODOROV COLLAGEN CORNEAL SHLD (November 29, 1988)
  • K875014 — LABTICIAN RETINAL IMPLANTS (February 26, 1988)
  • K831773 — MAI HYDROSEAL IMPLANT FOR SCLERAL BUCK (August 16, 1983)