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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K781672
Device Name ACU-DOT
Applicant
Acu-Dot Pharmaceutical Intl., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Acu-Dot Pharmaceutical Intl., Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Date Received10/03/1978
Decision Date 11/08/1978
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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