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510(k) K864639

REUSABLE SURGICAL KERATOSCOPE by Jedmed Instrument Co. — Product Code HLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1986
Date Received
November 26, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratoscope, Battery-Powered
Device Class
Class I
Regulation Number
886.1350
Review Panel
OP
Submission Type

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Other clearances for product code HLR

  • K901553 — SURG-K SURGICAL KERATOMETER (July 20, 1990)
  • K882902 — QRK 100, QUALITATIVE RING KERATOSCOPE (August 4, 1988)
  • K882618 — JEDMED/POLACK KERATOSCOPE HS/SL (July 13, 1988)
  • K854054 — PLACIDO DISC (December 27, 1985)
  • K830008 — KARICKHOFF KERATOSCOPE (January 26, 1983)
  • K821080 — HAND KERATOSCOPE (May 24, 1982)