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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Gas, Anesthetic
510(k) Number K951043
Device Name AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK
Applicant
Promedic, Inc.
10415 Briggs Ct.
Indianapolis,  IN  46256
Applicant Contact PAUL E DRYDEN
Correspondent
Promedic, Inc.
10415 Briggs Ct.
Indianapolis,  IN  46256
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received03/07/1995
Decision Date 06/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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