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510(k) K851906

SURGICAL EYE PACK by Xanmed Corp. — Product Code HMP

K851906 is an FDA 510(k) premarket notification submitted by Xanmed Corp. for the device "SURGICAL EYE PACK". The FDA issued a decision of Substantially Equivalent on May 21, 1985. The device falls under product code HMP (Pad, Eye), a Class I device regulated under 21 CFR 878.4440. Xanmed Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1985
Date Received
May 1, 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 by Xanmed Corp.

  • K864623 — OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT (January 14, 1987)
  • K844595 — ORTHOPEDIC CUSTOM SURGICAL KIT (August 21, 1985)
  • K844596 — EMERGENCY ROOM & MINOR OFFICE PROCEDURE CUSTOM KIT (August 1, 1985)
  • K844593 — CARDIOVASCULAR CUSTOM SURGICAL KIT (June 21, 1985)
  • K844594 — NEURO CUSTOM SURGICAL KIT (June 13, 1985)
  • K844597 — MISCELLANEOUS GENERAL SURGICAL CUSTOM KIT (April 8, 1985)
  • K843641 — CATHETER INTRODUCER SYSTEM (October 23, 1984)
  • K843642 — SUBCLAVIAN LEAD INTRODUCER SYS (October 23, 1984)

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)
  • K850005 — VISOPROTECT OCCULAR SHIELD (March 20, 1985)
  • K850099 — VISOPROTECT: OCCULAR SHIELD (March 20, 1985)

FDA data resources