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510(k) K882902

QRK 100, QUALITATIVE RING KERATOSCOPE by Technitex, Inc. — Product Code HLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1988
Date Received
July 12, 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 by Technitex, Inc.

  • K893968 — VKG 2000 VIDEO KERATOMETER (September 11, 1989)
  • K883471 — VKG 1000, VIDEO KERATOMETER (November 8, 1988)

Other clearances for product code HLR

  • K901553 — SURG-K SURGICAL KERATOMETER (July 20, 1990)
  • 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)