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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name chamber, oxygen, topical, extremity
510(k) Number K002632
Device Name OXYGENATOR
Applicant
ADJUNCTIVE THERAPEUTICS, INC.
10 SCOTCH MIST COURT
POTOMAC,  MD  20854
Applicant Contact MYRON Z BERNSTEIN
Correspondent
ADJUNCTIVE THERAPEUTICS, INC.
10 SCOTCH MIST COURT
POTOMAC,  MD  20854
Correspondent Contact MYRON Z BERNSTEIN
Regulation Number878.5650
Classification Product Code
KPJ  
Date Received08/23/2000
Decision Date 10/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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