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510(k) K020482

KERATOME BLADE 200200 & 600600 by Micro Specialties, Inc. — Product Code HNO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2002
Date Received
February 13, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratome, Ac-Powered
Device Class
Class I
Regulation Number
886.4370
Review Panel
OP
Submission Type

Other clearances by Micro Specialties, Inc.

  • K033457 — M2 COMPATIBLE MICROKERATOME BLADE (May 25, 2004)
  • K980508 — KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERA (May 1, 1998)
  • K980510 — KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICR (May 1, 1998)

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