Atlas FDA

UTAH ARTIFICAL ARM

FDA 510(k) clearance K802642 · decided 1980-11-12

Clearance details

K-number
K802642
Device name
UTAH ARTIFICAL ARM
Applicant
Motion Control, Inc.
Decision
Substantially Equivalent
Date received
1980-10-24
Decision date
1980-11-12
Days to decision
19 days
Clearance type
Traditional
Product code
IRE
Device class
1
Regulation number
890.3420
Medical specialty
Physical Medicine
Advisory committee
Physical Medicine
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ELBOW PROSTHESIS (K822632)Hosmer Dorrance Corp.1982-09-14

Recalls involving this device

No recalls on record reference this clearance.