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510(k) K942747

MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) by Engineered Orthopedic Technologies, Inc. — Product Code KDP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1994
Date Received
June 10, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Vacuum
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Engineered Orthopedic Technologies, Inc.

  • K874298 — MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME (February 4, 1988)

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  • K883229 — OHMEDA CONTINUOUS SUCTION REGULATOR (October 19, 1988)
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  • K853155 — BOEHRINGER LAB SUCTION INTERRUPTER (October 16, 1985)
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  • K843591 — INTERCEPT (October 19, 1984)