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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pin, Retentive And Splinting, And Accessory Instruments
510(k) Number K895283
Device Name PROSTHETIC RESTORATION DEVICE
Applicant
Swiss Precision Mfg. Corp.
66 (E) S. Second St.
Bayshore,  NY  11706
Applicant Contact ROGER K ALETRAS
Correspondent
Swiss Precision Mfg. Corp.
66 (E) S. Second St.
Bayshore,  NY  11706
Correspondent Contact ROGER K ALETRAS
Regulation Number872.3740
Classification Product Code
EBL  
Date Received08/24/1989
Decision Date 02/14/1990
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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