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510(k) K961742

DRAGER DVE 8080/81/82 WITH DVE 4002 OR DVE 4001 SERIES SYSTEM by Alm Surgical Equipment, Inc. — Product Code FQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1996
Date Received
May 6, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Operating-Room, Ac-Powered
Device Class
Class I
Regulation Number
878.4960
Review Panel
SU
Submission Type

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  • K945102 — MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE (November 4, 1994)
  • K942043 — DRAGER DVE 8000/1/2 SERIES SYST W/DVE 4002 AND 8032E (July 13, 1994)
  • K922409 — ALM ILLUMINATOR SERIES LIGHT SYSTEM (January 12, 1993)
  • K921297 — DRAGER DVE 4000 SERIES SYSTEM (November 27, 1992)
  • K921848 — BFW WEHMERLITE IV-A FIBER OPTIC SURG. HEADLIGHT (October 1, 1992)
  • K884019 — ALM OPERATING TABLES (October 13, 1988)
  • K882613 — ALM SURGICAL LAMPS (July 18, 1988)

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