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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Noninvasive
510(k) Number K882315
Device Name VIR-A-VAC EMPTY
Applicant
Viratec Corp.
150 Marbledale Rd.
Tuckahoe,  NY  10707
Applicant Contact ALLEN P SCHLEIN
Correspondent
Viratec Corp.
150 Marbledale Rd.
Tuckahoe,  NY  10707
Correspondent Contact ALLEN P SCHLEIN
Regulation Number880.6740
Classification Product Code
GAZ  
Date Received06/03/1988
Decision Date 09/26/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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