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510(k) K813315

CALIPER-OPTHALMIC by Design Research Assoc., Inc. — Product Code HOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1982
Date Received
November 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Caliper, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Design Research Assoc., Inc.

  • K813313 — BIOMICROSCOPY CONTACT LENS (March 1, 1982)
  • K813314 — NLD IMPLANT SET (February 24, 1982)

Other clearances for product code HOE

  • K881094 — KOI(TM) BLADE GAUGE, MODEL KOI-132 (April 1, 1988)
  • K820050 — KREMER BLADE GAUGE (February 24, 1982)
  • K812011 — BLADE GAUGE (July 28, 1981)
  • K801937 — BLEPHAROMETER (September 16, 1980)
  • K792383 — KELMAN DIPSTICK (December 11, 1979)
  • K781715 — RULER, WECK SCOTT (December 4, 1978)