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510(k) K860977

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

K860977 is an FDA 510(k) premarket notification submitted by Britt Corp., Inc. for the device "MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION". The FDA issued a decision of Substantially Equivalent on October 16, 1986. The device falls under product code LLF (Laser, Neurosurgical, Argon), a Class III device. Britt Corp., Inc. has at least 10 other 510(k) clearances on record.

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

Other clearances by Britt Corp., Inc.

  • K003828 — VASO PRESS DVT FOOT GARMENT #VP 520 (May 18, 2001)
  • K991038 — VASO PRESS DVT SYSTEM, MODELS VP500, VP501 (June 22, 2000)
  • K974393 — VASO PRESS SYSTEM (March 19, 1999)
  • K860975 — MODEL 545-45 LASER FOR EAR, NOSE & THROAT (July 18, 1986)
  • K860974 — MODEL 545-45 LASER FOR DERMA., POD., SURGICAL (July 7, 1986)
  • K860277 — MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT (May 6, 1986)
  • K860273 — MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY (April 23, 1986)
  • K860278 — MODEL 525-25 WATT CO2 LASER FOR DERMA/PLASTIC (April 15, 1986)
  • K851425 — MODEL J25-25 WATT CO2 LASER (November 12, 1985)
  • K840036 — FITEX (October 26, 1984)

Other clearances for product code LLF

  • K870773 — ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER (July 10, 1987)
  • K864610 — CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE (June 18, 1987)
  • K833497 — COOPER MEDICAL MODEL 770 (April 17, 1984)

FDA data resources