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510(k) K861456

SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR by Pantheon Products, Inc. — Product Code HMP

K861456 is an FDA 510(k) premarket notification submitted by Pantheon Products, Inc. for the device "SHEETS LYOPHILIZED COLLAGEN HEYEDRATOR". The FDA issued a decision of SN on July 25, 1986. The device falls under product code HMP (Pad, Eye), a Class I device regulated under 21 CFR 878.4440.

Clearance Details

Decision
SN ()
Decision Date
July 25, 1986
Date Received
April 18, 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 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)
  • 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