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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cabinet, phototherapy (puva)
510(k) Number K820280
Device Name SPECTRA 305/350
Applicant
ULTRALITE
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ULTRALITE
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number878.4630
Classification Product Code
KGL  
Date Received02/02/1982
Decision Date 03/05/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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