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510(k) K082087

EYEFEEL OPHTHALMIC WARMER by Bio-Lipid, Inc. — Product Code IMD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2008
Date Received
July 23, 2008
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 Bio-Lipid, Inc.

  • K021843 — EYEFEEL OPHTHALMIC WARMER (September 3, 2002)

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)
  • 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)
  • K970399 — KWIK KOLD PERI COLD PACK (CATALOG NUMBER TBD) (April 3, 1997)