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510(k) K850099

VISOPROTECT: OCCULAR SHIELD by Rockway Enterprises, Inc. — Product Code HMP

K850099 is an FDA 510(k) premarket notification submitted by Rockway Enterprises, Inc. for the device "VISOPROTECT: OCCULAR SHIELD". The FDA issued a decision of Substantially Equivalent on March 20, 1985. The device falls under product code HMP (Pad, Eye), a Class I device regulated under 21 CFR 878.4440.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1985
Date Received
January 11, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Eye
Device Class
Class I
Regulation Number
878.4440
Review Panel
SU
Submission Type

Other clearances for product code HMP

  • K940333 — EYE PAD (March 7, 1994)
  • K921349 — STERILE,DISPOSABLE EYE DRESSING (May 29, 1992)
  • K904896 — EYE PAD (December 5, 1990)
  • K883822 — FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309 (November 22, 1988)
  • K874411 — DONALDSON NATURAL EYEPATCH 'PATIENT PAK' (January 27, 1988)
  • K864810 — LIDSPLINT (January 20, 1987)
  • K861456 — SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR (July 25, 1986)
  • K860979 — DONALDSON NATURAL EYEPATCH (April 4, 1986)
  • K851906 — SURGICAL EYE PACK (May 21, 1985)
  • K850005 — VISOPROTECT OCCULAR SHIELD (March 20, 1985)

FDA data resources