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510(k) K781539

ISO-CARE KIT by Nice-Pak Products, Inc. — Product Code HMP

K781539 is an FDA 510(k) premarket notification submitted by Nice-Pak Products, Inc. for the device "ISO-CARE KIT". The FDA issued a decision of Substantially Equivalent on November 3, 1978. The device falls under product code HMP (Pad, Eye), a Class I device regulated under 21 CFR 878.4440. Nice-Pak Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1978
Date Received
September 8, 1978
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 Nice-Pak Products, Inc.

  • K974768 — PDI STERILE LUBRICATING JELLY (January 16, 1998)
  • K840342 — PDI PREPMASTER WET PACK PATIENT PREP KIT (March 27, 1984)
  • K840343 — PDI PREPMASTER WET PACK VAGINAL-X21477 (March 27, 1984)
  • K840344 — PDI PREPMASTER WET PACK MINOR PROCEDURE (March 26, 1984)
  • K833549 — PDI SURGICAL SCRUB/BRUSH T150-70 (November 28, 1983)
  • K810337 — PDI SURGICAL SCRUB SPONGE-BRUSH-T15070 (February 26, 1981)
  • K780279 — ICE-PAK, PDI (April 10, 1978)
  • K780400 — DEN-Z-ORB (March 27, 1978)

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

FDA data resources