510(k) K833285

RX IV PENTRON IV by Genesis Industries, Inc. — Product Code EIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1983
Date Received
September 22, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Remover, Crown
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type