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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Dental
510(k) Number K851640
Device Name TIP TOLEDO INCISOR PROTECTOR
Applicant
EDWARD O. GOODWICH
1600 HAGYS RD. 5V
NARBERTH,  PA  19072
Applicant Contact EDWARD O GOODWICH
Correspondent
EDWARD O. GOODWICH
1600 HAGYS RD. 5V
NARBERTH,  PA  19072
Correspondent Contact EDWARD O GOODWICH
Regulation Number868.5820
Classification Product Code
BRW  
Date Received04/11/1985
Decision Date 09/18/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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