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510(k) K854054

PLACIDO DISC by Cutler Medical Instruments — Product Code HLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1985
Date Received
October 3, 1985
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

Other clearances by Cutler Medical Instruments

  • K862343 — VACUUM HANDLE MODEL I/A - 1 (July 11, 1986)

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)
  • K864639 — REUSABLE SURGICAL KERATOSCOPE (December 29, 1986)
  • K830008 — KARICKHOFF KERATOSCOPE (January 26, 1983)
  • K821080 — HAND KERATOSCOPE (May 24, 1982)