Atlas FDA

JTECH ADJUSTER REFLEX GUN

FDA 510(k) clearance K974376 · decided 1998-02-18

Clearance details

K-number
K974376
Device name
JTECH ADJUSTER REFLEX GUN
Applicant
J-Tech Medical, Inc.
Decision
Substantially Equivalent
Date received
1997-11-20
Decision date
1998-02-18
Days to decision
90 days
Clearance type
Traditional
Product code
LXM
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Crofton, MD, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.