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510(k) K982082

HANDISOL WOUND HEALING by National Biological Corp. — Product Code FTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1998
Date Received
June 15, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Ultraviolet, Dermatological
Device Class
Class II
Regulation Number
878.4630
Review Panel
SU
Submission Type

Other clearances by National Biological Corp.

  • K070934 — PANOSOL II TRU-BLU, MODEL UBL-417 (May 22, 2007)
  • K041212 — HOUVA 3 PHOTOTHERAPY SYSTEM (June 9, 2004)
  • K934808 — UVISOL AND UVISOL II (December 16, 1993)
  • K924969 — PHOTOTHERAPY TIMER (February 23, 1993)
  • K924077 — HANDISOL (November 20, 1992)
  • K904428 — PANOSOL II UAB-228 (December 24, 1990)
  • K904426 — PANOSOL II UVA-218 (December 24, 1990)
  • K904427 — PANOSOL II UVB-206 (December 24, 1990)
  • K885029 — HOUVA II UVA/UVB (June 2, 1989)
  • K885026 — HOUVA II UVB (June 2, 1989)

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