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510(k) K031549

SOLID STATE LAMP [LED] HEADLIGHT by Welch Allyn, Inc. — Product Code FSR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2003
Date Received
May 16, 2003
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Headband, Surgical
Device Class
Class II
Regulation Number
886.4335
Review Panel
OP
Submission Type

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Other clearances for product code FSR

  • K110528 — INTEGRA LED SURGICAL HEADLIGHT SYSTEM (May 11, 2011)
  • K031548 — LED HEADLIGHT (August 11, 2003)
  • K994362 — HEADLAMP HL2000. (May 11, 2000)