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510(k) K822644

RIWOLITH 2135 by R. Wolf Medical Instruments Corp. — Product Code FFK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1982
Date Received
September 1, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lithotriptor, Electro-Hydraulic
Device Class
Class II
Regulation Number
876.4480
Review Panel
GU
Submission Type

Other clearances by R. Wolf Medical Instruments Corp.

  • K810284 — AUTOMATIC TEFLON INJECTION SYRINGE (March 11, 1981)

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