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510(k) K790993

INSTANT HOT & COLD PACKS by Chase Mfg. Co. — Product Code IMD

K790993 is an FDA 510(k) premarket notification submitted by Chase Mfg. Co. for the device "INSTANT HOT & COLD PACKS". The FDA issued a decision of Substantially Equivalent on September 7, 1979. The device falls under product code IMD (Pack, Hot Or Cold, Disposable), a Class I device regulated under 21 CFR 890.5710. Chase Mfg. Co. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1979
Date Received
May 29, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Disposable
Device Class
Class I
Regulation Number
890.5710
Review Panel
PM
Submission Type

Other clearances by Chase Mfg. Co.

  • K791513 — ADAMCO DUST COVER (October 11, 1979)
  • K790644 — SUBMAX (April 26, 1979)
  • K780033 — MATTRESSES, CONDUCTIVE & COVERS (February 21, 1978)
  • K771792 — ENEMA SET (October 20, 1977)
  • K771791 — NEEDLE COUNTING (October 4, 1977)
  • K770900 — CAST BRWM, FRACTURE (July 21, 1977)
  • K770898 — FRACTURE CAST BRACE KIT, PLASTIC (July 21, 1977)
  • K770899 — FRACTURE CAST BRACE, POLY (July 21, 1977)
  • K770173 — STOCKINETTE (February 8, 1977)

Other clearances for product code IMD

  • K221653 — InfaTherm Disposable Infant Warming Mattress (October 6, 2022)
  • K163295 — Infant Transport Mattress Warmer with Disc (July 24, 2017)
  • K112547 — NEO NEST (March 6, 2012)
  • K082087 — EYEFEEL OPHTHALMIC WARMER (September 11, 2008)
  • K071710 — BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) (August 14, 2007)
  • K021843 — EYEFEEL OPHTHALMIC WARMER (September 3, 2002)
  • K982652 — ALLEGIANCE PORTA-WARM MATTRESS (January 21, 1999)
  • K980509 — DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS (February 26, 1998)
  • K974190 — CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER (November 19, 1997)
  • K973770 — ALLEGIANCE KWIK HEAT WARM PERINEAL PACK (November 13, 1997)

FDA data resources