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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Syringe, Air And/Or Water
510(k) Number K942519
Device Name UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS
Applicant
Bull Frog Mfg. Co.
5304 N. Albina
Portland,  OR  97217
Applicant Contact CHARLES W HUTCHINS
Correspondent
Bull Frog Mfg. Co.
5304 N. Albina
Portland,  OR  97217
Correspondent Contact CHARLES W HUTCHINS
Regulation Number872.4565
Classification Product Code
ECB  
Date Received05/26/1994
Decision Date 08/23/1994
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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