FITPACK

FDA 510(k) clearance K060037 · decided 2006-07-25

Clearance details

K-number: K060037
Device name: FITPACK
Applicant: Asp Plastics Pty , Ltd.
Decision: Substantially Equivalent
Date received: 2006-01-06
Decision date: 2006-07-25
Days to decision: 200 days
Clearance type: Traditional
Product code: MMK
Device class: 2
Regulation number: 880.5570
Medical specialty: General Hospital
Advisory committee: General Hospital
Location: Mission Viejo, CA, US
Third-party review: No
Expedited review: No

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Recalls involving this device

No recalls on record reference this clearance.