Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)

FDA 510(k) K143317 · Currie Medical Specialties, Inc.

Substantially Equivalent

510(k) numberK143317

Submission

Device name
Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes)
Applicant
Currie Medical Specialties, Inc.
Rancho Cucamonga, CA, US
Received
November 19, 2014
Decision date
January 20, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JOW – Sleeve, Limb, Compressible
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5800
Specialty
Cardiovascular

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More from Manamed, LLC

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K112311Alp 501 RB Pump SystemJOW · Special 09/01/2011SE
K902441Disposable Procedural Trays #Ck-Xxxxx (Various)KDD · Traditional 08/23/1990SEKD
K874760CK 4900 Series, Gown and Towel PakLRO · Traditional 12/10/1987SE
K872395CK 1600 Series, TowelsKKX · Traditional 07/02/1987SE
K871737CK 7000 Series 5 in 1 Connector and Y-ConnectorBZA · Traditional 06/22/1987SE
K864816CK 5000 Series, Ace Bandage/Esmark Bandage · Traditional 01/08/1987SE
K864697CK 6000 Series, TowelsKKX · Traditional 12/18/1986SE
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Questions and answers

When was Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) cleared by the FDA?

Currie Medical ALP Pediatric Calf Compression Sleeves (all sizes) (K143317) received a 510(k) decision of Substantially Equivalent on January 20, 2015, 62 days after the submission was received.

What is the product code of K143317?

The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.