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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bottle, Collection, Vacuum
510(k) Number K941818
Device Name PM9000 VAC TRAP
Applicant
Precision Medical, Inc.
300 Held Dr.
Northampton,  PA  18067
Applicant Contact MICHAEL A KRUPA
Correspondent
Precision Medical, Inc.
300 Held Dr.
Northampton,  PA  18067
Correspondent Contact MICHAEL A KRUPA
Regulation Number880.6740
Classification Product Code
KDQ  
Date Received04/13/1994
Decision Date 12/12/1994
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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