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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K852154
Device Name ACKRAD SIALOGRAPHY CATHETER
Applicant
Ackrad Laboratories
70 Jackson Dr.
Cranford,  NJ  07016
Applicant Contact BERNARD ACKERMAN
Correspondent
Ackrad Laboratories
70 Jackson Dr.
Cranford,  NJ  07016
Correspondent Contact BERNARD ACKERMAN
Date Received05/17/1985
Decision Date 06/26/1985
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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