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510(k) K841897

FIRST RESPONSE EMERG. MEDICAL SYSTEM by Reed Products, Inc. — Product Code KGX

K841897 is an FDA 510(k) premarket notification submitted by Reed Products, Inc. for the device "FIRST RESPONSE EMERG. MEDICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on July 23, 1984. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Reed Products, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1984
Date Received
May 7, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type

Other clearances by Reed Products, Inc.

  • K841898 — FIRST RESPONSE EMERG. MEDICSL - BURNS (August 14, 1984)
  • K841900 — FIRST RESPONSE EMERG. EYE INJURIES (July 23, 1984)
  • K841899 — FIRST RESPONSE EMERG. MEDICAL SYS BONES (July 23, 1984)

Other clearances for product code KGX

  • K001240 — SERAGARD INJECTION PATCH (June 21, 2000)
  • K983368 — CARE BAND ANTIBACTERIAL BANDAGES (February 17, 1999)
  • K972914 — SYVEK PATCH (December 22, 1997)
  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (January 17, 1996)
  • K952606 — TARGETT PATCH (December 21, 1995)
  • K954007 — PARALLEL (November 22, 1995)
  • K944587 — DERMIVIEW HYPOALLERGENIC CLEAR TAPE (October 30, 1995)
  • K944588 — STERILE PLASTIC DRESSING (November 7, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)

FDA data resources