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510(k) K844852

THE GENERIC OXYGEN CONCENTRATOR by Proto-Med, Inc. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1984
Date Received
December 13, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type

Other clearances by Proto-Med, Inc.

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  • K811761 — THE EMMETT IUD THREAD RETRIEVER (September 21, 1981)

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