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510(k) K841795

UV 8001K, PUVA 800, PUVA 180/200 1000 by Waldmann Lighting Co. — Product Code KGL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1984
Date Received
May 2, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cabinet, Phototherapy (Puva)
Device Class
Class II
Regulation Number
878.4630
Review Panel
SU
Submission Type

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  • K810358 — PHOTOTHERAPY LIGHT CHAMBER (March 20, 1981)
  • K791977 — PSORALITE MARK I (December 28, 1979)
  • K791116 — PSORALITE SERIES 30,000 (September 4, 1979)
  • K761094 — UVA PHOTOTHERAPY SYSTEM (December 2, 1976)