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510(k) K864610

Device
CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE
Applicant
INFRAMED, INC.
510(k) number
K864610
Product code
LLF  
Decision
Substantially Equivalent (SESE)
Decision date
1987-06-18
Date received
1986-11-20
Regulation
510(k) Premarket Notification
Classification name
Laser, Neurosurgical, Argon
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Neurology
Device class
3
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TIM SHEA
Address
100 Crescent Rd. Needham MA US 02194 02194

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LLF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K870773ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASERHgm, Inc.1987-07-10
K860977MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATIONBritt Corp., Inc.1986-10-16
K833497COOPER MEDICAL MODEL 770Cooper Medical Corp.1984-04-17

Legacy Summary#

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FDA Review#

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