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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Periodontic, Endodontic, Irrigating
510(k) Number K851944
Device Name MAX-I-PROBE HANDPIECE
Applicant
Solo Pak Laboratories
3727 Mt. Prospect Rd.
Franklin Park,  IL  60131
Applicant Contact THOMAS F WILLER
Correspondent
Solo Pak Laboratories
3727 Mt. Prospect Rd.
Franklin Park,  IL  60131
Correspondent Contact THOMAS F WILLER
Regulation Number872.4565
Classification Product Code
EIC  
Date Received05/03/1985
Decision Date 07/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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