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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K861292
Device Name CASTALERT
Applicant
Walgen Medical Innoventions
1201 E. Genesee St.
Syracuse,  NY  13210
Applicant Contact SUGARMAR, MD
Correspondent
Walgen Medical Innoventions
1201 E. Genesee St.
Syracuse,  NY  13210
Correspondent Contact SUGARMAR, MD
Date Received04/07/1986
Decision Date 05/12/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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