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510(k) K962087

SERVOTRONIC EC100 SYSTEM by Medicon, Inc. — Product Code HWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1997
Date Received
May 28, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

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  • K844573 — ABSORBABLE GAUZE PRODUCTS (March 5, 1985)
  • K844574 — WHEELCHAIRS (February 21, 1985)
  • K844703 — GOWNS, SURGICAL (January 10, 1985)
  • K844704 — CAPS (O.R. NURSE, SURGICAL) (January 10, 1985)
  • K844705 — SHOE COVERS (January 10, 1985)
  • K840034 — VACUUM STRETCHER IMMOBILIZER (February 27, 1984)

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