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510(k) K871006

EDCOOL AND EDCOOL JR. INSTANT COLD PACK by Advantage Credit Services, Inc. — Product Code IMP

K871006 is an FDA 510(k) premarket notification submitted by Advantage Credit Services, Inc. for the device "EDCOOL AND EDCOOL JR. INSTANT COLD PACK". The FDA issued a decision of Substantially Equivalent on March 25, 1987. The device falls under product code IMP (Cushion, Wheelchair), a Class I device regulated under 21 CFR 890.3920. Advantage Credit Services, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1987
Date Received
March 13, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cushion, Wheelchair
Device Class
Class I
Regulation Number
890.3920
Review Panel
PM
Submission Type

Other clearances by Advantage Credit Services, Inc.

  • K871005 — 18X36,36X36,18X72,24X72 GAUZE COMPRESS (March 31, 1987)
  • K870993 — 2, 3 AND 4 BANDAGE COMPRESS (March 31, 1987)
  • K871002 — 1X5YD,2X6YD,3X5YD,4X6YD,1/2/3X10YD GAUZE (March 31, 1987)

Other clearances for product code IMP

  • K890653 — ULTIMA WHEELCHAIR CUSHION (February 28, 1989)

FDA data resources