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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K837382
Device Name OPTISON ULTRASONIC SCALER
Applicant
Pelton & Crane Co.
200 Clanton Rd.
Charlotte,  NC  28224
Correspondent
Pelton & Crane Co.
200 Clanton Rd.
Charlotte,  NC  28224
Date Received03/04/1983
Decision Date 05/06/1983
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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