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510(k) K964619

DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL) by Sds Dental, Inc. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1997
Date Received
November 18, 1996
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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  • K863007 — EUROFLEX F-IV, ISOFLEX III (October 1, 1986)
  • K863014 — ISOPRAT F-III SET/ISOLAX CHAIR (October 1, 1986)

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