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510(k) K851425

MODEL J25-25 WATT CO2 LASER by Britt Corp., Inc. — Product Code HHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1985
Date Received
April 10, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Surgical, Gynecologic
Device Class
Class II
Regulation Number
884.4550
Review Panel
OB
Submission Type

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  • K860977 — MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION (October 16, 1986)
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  • K860273 — MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY (April 23, 1986)
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  • K840020 — FITNESS LOGGER (October 26, 1984)

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  • K874615 — LASER CANNISTER FILTER (June 23, 1988)
  • K880591 — LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE (June 1, 1988)
  • K880930 — MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE (May 31, 1988)
  • K880991 — LASER OPTICAL CATHETER SYSTEM (May 25, 1988)
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  • K874837 — KTP/532 LASER FOR OB-GYN USE (March 14, 1988)
  • K875078 — HERACURE LS 500 (February 22, 1988)