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510(k) K915353

MATRX MEDICAL MAXIMIZER 1000 AND 2000 VACUUM PUMP by Matrix Medica, Inc. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1991
Date Received
November 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

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  • K883833 — NITRONOX(R), FIRST RESPONSE NITRONOX(TM) (February 17, 1989)
  • K884879 — CENTURION(TM) MIXER (February 9, 1989)

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