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510(k) K860977

MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION by Britt Corp., Inc. — Product Code LLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1986
Date Received
March 14, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Neurosurgical, Argon
Device Class
Class III
Regulation Number
Review Panel
NE
Submission Type

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  • K860278 — MODEL 525-25 WATT CO2 LASER FOR DERMA/PLASTIC (April 15, 1986)
  • K851425 — MODEL J25-25 WATT CO2 LASER (November 12, 1985)
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Other clearances for product code LLF

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  • K864610 — CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE (June 18, 1987)
  • K833497 — COOPER MEDICAL MODEL 770 (April 17, 1984)