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510(k) K780452

THERA-PAK by Hydro-Med Products, Inc. — Product Code ILO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1978
Date Received
March 21, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Water Circulating
Device Class
Class II
Regulation Number
890.5720
Review Panel
PM
Submission Type

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  • K834407 — STERILE DISPOSABLE SPINAL NEEDLES (March 19, 1984)
  • K812405 — STERILE TV CAMERA & CORD COVER (October 20, 1981)

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