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510(k) K801937

BLEPHAROMETER by Aztec Medical Products, Inc. — Product Code HOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1980
Date Received
August 12, 1980
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 Aztec Medical Products, Inc.

  • K801939 — RHYTIDOMETER (September 26, 1980)
  • K801938 — RHINOMETER (September 9, 1980)
  • K792608 — TEGTMEIER MAMMOMETER (January 4, 1980)
  • K791221 — TEGTMEIER MAMMOMETER (July 3, 1979)

Other clearances for product code HOE

  • K881094 — KOI(TM) BLADE GAUGE, MODEL KOI-132 (April 1, 1988)
  • K813315 — CALIPER-OPTHALMIC (March 1, 1982)
  • K820050 — KREMER BLADE GAUGE (February 24, 1982)
  • K812011 — BLADE GAUGE (July 28, 1981)
  • K792383 — KELMAN DIPSTICK (December 11, 1979)
  • K781715 — RULER, WECK SCOTT (December 4, 1978)