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510(k) K926314

HYDRA FITNESS MODEL 311 TOTAL POWER by Henley Intl. — Product Code ISD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1994
Date Received
December 15, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Measuring
Device Class
Class II
Regulation Number
890.5360
Review Panel
PM
Submission Type

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  • K926316 — TRUE-TRAC, STRATUS (March 24, 1993)
  • K920983 — SONOPULS 590 (March 9, 1993)
  • K922020 — ENDOMED 582 (September 22, 1992)

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