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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Regulator, Vacuum
510(k) Number K820706
Device Name WATERLESS SEAL & VACUUM REGULATOR
Applicant
Sorensen Research
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Sorensen Research
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number880.6740
Classification Product Code
KDP  
Date Received03/16/1982
Decision Date 04/09/1982
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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