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510(k) K771002

ICE BAND by Norcliff Thayer, Inc. — Product Code IME

K771002 is an FDA 510(k) premarket notification submitted by Norcliff Thayer, Inc. for the device "ICE BAND". The FDA issued a decision of Substantially Equivalent on August 30, 1977. The device falls under product code IME (Pack, Hot Or Cold, Reusable), a Class I device regulated under 21 CFR 890.5700. Norcliff Thayer, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1977
Date Received
June 2, 1977
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 Norcliff Thayer, Inc.

  • K890290 — BRACE (ORAFIX SPECIAL) (March 29, 1989)
  • K791576 — FORGET - DENTURE BONDING LIQUID (October 26, 1979)
  • K780174 — ORABRITE (February 23, 1978)

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