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510(k) K803299

COLD/HOT PACK by W.G. Whitney Corp. — Product Code IME

K803299 is an FDA 510(k) premarket notification submitted by W.G. Whitney Corp. for the device "COLD/HOT PACK". The FDA issued a decision of Substantially Equivalent on January 15, 1981. The device falls under product code IME (Pack, Hot Or Cold, Reusable), a Class I device regulated under 21 CFR 890.5700. W.G. Whitney Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1981
Date Received
December 30, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Reusable
Device Class
Class I
Regulation Number
890.5700
Review Panel
PM
Submission Type

Other clearances by W.G. Whitney Corp.

  • K834532 — STERILE WET DRESSING PACK (January 25, 1984)
  • K813535 — XEROFORM DRESSING (February 4, 1982)
  • K810406 — STERILE WET DRESSING PACK (March 11, 1981)
  • K800907 — TOMAC WET DRESSING WARMER (May 20, 1980)
  • K781322 — STERILE WET DRESSING PACK (August 17, 1978)
  • K770387 — UNICATCH (April 5, 1977)

Other clearances for product code IME

  • K923627 — COLD PACK (April 14, 1993)
  • K915876 — HOTPAD (February 12, 1993)
  • K921446 — HOT OR COLD PACK (THERMIPAQ) (July 13, 1992)
  • K905207 — MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS (January 22, 1991)
  • K882413 — SUBOCCIPITAL ICE PILLOW (November 30, 1988)
  • K863654 — RE-HEATER, HOT PACK (October 23, 1986)
  • K832193 — NICE PACK (August 31, 1983)
  • K831899 — ENSWELL (July 7, 1983)
  • K830981 — MICROPAK MOIST HEAT PAD (June 3, 1983)
  • K830416 — ICY COLD ICE CAP (March 10, 1983)

FDA data resources