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510(k) K082208

Device
DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER
Applicant
SCIVOLUTIONS, INC.
510(k) number
K082208
Product code
NAC  
Decision
Substantially Equivalent (SESE)
Decision date
2008-12-01
Date received
2008-08-05
Regulation
878.4018
Classification name
Dressing, Wound, Hydrophilic
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ARTHUR WARD
Address
962 Allegro Ln. Appollo Beach FL US 33572 33572

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NAC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K925841HYDRASORB JOYCE SPONGEAvitar, Inc.1993-05-12
K914575SORBSAN TOPICAL WOUND DRESSING (MODIFIED)Dow B. Hickam, Inc.1991-12-04
K914779ALGINATE FIBERAdri/Technam1991-12-04

Legacy Summary#

summary

FDA Review#

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