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510(k) K901553

SURG-K SURGICAL KERATOMETER by The Sanborn Co. — Product Code HLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 1990
Date Received
April 3, 1990
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 The Sanborn Co.

  • K901523 — VKG 1000, VIDEO KERATOGRAPH (June 27, 1990)

Other clearances for product code HLR

  • 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)
  • K830008 — KARICKHOFF KERATOSCOPE (January 26, 1983)
  • K821080 — HAND KERATOSCOPE (May 24, 1982)