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510(k) K811577

CROUCH CORNEAL PROTECTOR by Denver Biomedicals, Inc. — Product Code HOY

K811577 is an FDA 510(k) premarket notification submitted by Denver Biomedicals, Inc. for the device "CROUCH CORNEAL PROTECTOR". The FDA issued a decision of Substantially Equivalent on August 7, 1981. The device falls under product code HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)), a Class I device regulated under 21 CFR 886.4750. Denver Biomedicals, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1981
Date Received
June 5, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Device Class
Class I
Regulation Number
886.4750
Review Panel
OP
Submission Type

Other clearances by Denver Biomedicals, Inc.

  • K051084 — DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE (June 13, 2005)
  • K011020 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (June 1, 2001)
  • K010642 — PLEURX PLEURAL CATHETER AND DRAINAGE KITS (March 20, 2001)
  • K003451 — DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHU (January 2, 2001)
  • K943968 — TUNNELER (March 1, 1995)
  • K913728 — DENVER(R) PERITONEO-SUBCLAVIAN SHUNT (February 18, 1994)
  • K842139 — THE DENVER PLEURAL-PERITONEAL SHUNT (August 27, 1984)
  • K822686 — DENVER PERITONEO-VENOUS SHUNT (DP-VS) (September 21, 1982)
  • K811183 — DENVER PERITONEO-VENOUS SHUNT (July 1, 1981)

Other clearances for product code HOY

  • K132042 — AMB101 SYSTEM, AMBLYZ, LCG SYSTEM, XPAND (April 28, 2014)
  • K050856 — LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM (May 31, 2005)
  • K971465 — NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS (June 4, 1997)
  • K944700 — ARCTIC PREMIER SERIES (December 22, 1994)
  • K944857 — GOGGLE SAFEGUARD (December 15, 1994)
  • K945351 — SHIELD, EYE, OPHTHALMIC (December 13, 1994)
  • K945346 — MAKROLON 2405 GOGGLES (LIGHT AND DARK) (November 22, 1994)
  • K942407 — AMCON SLIP IN MYDRIATIC SUNGLASSES (June 6, 1994)
  • K941829 — SUN FILTERS/SHIELDS (May 17, 1994)
  • K930347 — SHAIDS PROTECTIVE GLASSES (April 29, 1994)

FDA data resources