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510(k) K940373

OPHTHALMIC CRYO UNIT by Dutch Ophthalmic USA, Inc. — Product Code HPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1994
Date Received
January 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Cryophthalmic
Device Class
Class II
Regulation Number
886.4170
Review Panel
OP
Submission Type

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  • K983797 — D.O.R.C. HARMONY TOTAL VITRECTOMY SYSTEM (March 3, 1999)
  • K980636 — FIBER OPTIC ENDOILLUMINATION PROBE (May 20, 1998)
  • K973229 — D.O.R.C. HEXON ILLUMINATION SYSTEM (November 25, 1997)
  • K973757 — D.O.R.C. SOLUX LIGHT SOURCE (November 7, 1997)
  • K962135 — D.O.R.C. MICRODIATHERMY SYSTEM (August 29, 1996)
  • K954842 — D.O.R.C. VFI/VFE SYSTEM (April 15, 1996)
  • K902491 — ECKHARDT TEMPORARY KERATOPROSTHESIS (June 26, 1990)

Other clearances for product code HPS

  • K202038 — CryoTreQ (December 30, 2020)
  • K923629 — OPHTHALMIC TRICHIASIS PROBE (October 19, 1992)
  • K903303 — SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES (October 11, 1990)
  • K874555 — KEELER ACU 22XT OPHTHALMIC CRYO UNIT (January 29, 1988)
  • K873388 — KEELER CTU CRYO SYSTEM (November 13, 1987)
  • K870195 — UNITED SURGICAL CORP. CRYOPTIC PLUS (February 20, 1987)
  • K833747 — GALLIE CRYONUCLEATOR (May 9, 1984)
  • K801418 — KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT (July 21, 1980)
  • K790102 — MODEL 556-01 CRYOEXTRACTOR (February 12, 1979)
  • K781338 — BEAVER CATARACT CYROXTRACTOR (February 12, 1979)