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510(k) K820050

KREMER BLADE GAUGE by Accutome, Inc. — Product Code HOE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1982
Date Received
January 8, 1982
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 Accutome, Inc.

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  • K132549 — ACCUTIP COVER (April 23, 2014)
  • K123349 — A-SCAN PLUS CONNECT (January 29, 2013)
  • K103471 — UBM PLUS (March 14, 2011)
  • K050552 — PACHPEN PACHYMETER, MODEL 24-5100 (March 28, 2005)
  • K032956 — ACCUSONIC A-SCAN MODEL, 24-4000 (October 10, 2003)
  • K810660 — KREMER CORNEOMETER ULTRASONIC PACHOMETER (August 21, 1981)

Other clearances for product code HOE

  • K881094 — KOI(TM) BLADE GAUGE, MODEL KOI-132 (April 1, 1988)
  • K813315 — CALIPER-OPTHALMIC (March 1, 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)