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510(k) K071710

BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) by Johnson & Johnson Consumer Products, Inc. — Product Code IMD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2007
Date Received
June 22, 2007
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 Johnson & Johnson Consumer Products, Inc.

  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (January 17, 1996)
  • K954007 — PARALLEL (November 22, 1995)
  • K951917 — JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS (May 10, 1995)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)
  • K935440 — JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED (February 3, 1994)
  • K840679 — SERENITY CONTOURED ABSORBENT SHIELDS (March 22, 1984)

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  • 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)