Atlas FDA

STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE

FDA 510(k) clearance K971187 · decided 1997-05-05

Clearance details

K-number
K971187
Device name
STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE
Applicant
Aaron Medical Industries
Decision
Substantially Equivalent
Date received
1997-04-01
Decision date
1997-05-05
Days to decision
34 days
Clearance type
Traditional
Product code
JOS
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
St. Petersburg, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.