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510(k) K864810

LIDSPLINT by Precision Therapeutics, Inc. — Product Code HMP

K864810 is an FDA 510(k) premarket notification submitted by Precision Therapeutics, Inc. for the device "LIDSPLINT". The FDA issued a decision of Substantially Equivalent on January 20, 1987. The device falls under product code HMP (Pad, Eye), a Class I device regulated under 21 CFR 878.4440. Precision Therapeutics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1987
Date Received
December 9, 1986
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 by Precision Therapeutics, Inc.

  • K872659 — TAPELESS EYE SHIELD (July 27, 1987)

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)
  • 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)
  • K850099 — VISOPROTECT: OCCULAR SHIELD (March 20, 1985)

FDA data resources