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510(k) K830008

KARICKHOFF KERATOSCOPE by Surgidev Corp. — Product Code HLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1983
Date Received
January 3, 1983
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 Surgidev Corp.

  • K850729 — ACUFLO VOLUMETRIC CONTROLLED DELIVERY SYS 2000 (April 9, 1985)
  • K831829 — KARICKHOFF FLYING CORPUSCLE VIEWER (October 19, 1983)
  • K831975 — LEADING EDGE OPHTHALMIC KNIFE (August 31, 1983)

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)
  • K854054 — PLACIDO DISC (December 27, 1985)
  • K821080 — HAND KERATOSCOPE (May 24, 1982)