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510(k) K882580

MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE by Precision Dynamics Corp. — Product Code JTW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1988
Date Received
June 21, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Transport, Aerobic
Device Class
Class I
Regulation Number
866.2900
Review Panel
MI
Submission Type

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