FRACTURE REDUCTION SYS., MODEL OR 1001— 510(k) K770388

Substantially Equivalent

Sisan Assoc.

FDA 510(k) clearance K770388 for FRACTURE REDUCTION SYS., MODEL OR 1001, Substantially Equivalent on 1977-03-14. Applicant: Sisan Assoc.. Device class: 2.

Clearance details

Applicant
Sisan Assoc.
Product code
Code JEC
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mchenry, IL, US
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