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510(k) K882618

JEDMED/POLACK KERATOSCOPE HS/SL by Gamut Ent. — Product Code HLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1988
Date Received
June 24, 1988
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 for product code HLR

  • K901553 — SURG-K SURGICAL KERATOMETER (July 20, 1990)
  • K882902 — QRK 100, QUALITATIVE RING KERATOSCOPE (August 4, 1988)
  • K864639 — REUSABLE SURGICAL KERATOSCOPE (December 29, 1986)
  • K854054 — PLACIDO DISC (December 27, 1985)
  • K830008 — KARICKHOFF KERATOSCOPE (January 26, 1983)
  • K821080 — HAND KERATOSCOPE (May 24, 1982)