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510(k) K820256

MEDILAC #SR4 & SR 40 by Spelna, Inc. — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1982
Date Received
January 29, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Spelna, Inc.

  • K852525 — SATALEC PIEZOTEC (January 30, 1986)
  • K852527 — SATALEC SEPTOSONIC SC 80/SC 120 (January 3, 1986)
  • K852522 — SATALEC SERVOTOME (December 27, 1985)
  • K853200 — 5X2 SATALEC CHIROPODY CASE (October 18, 1985)
  • K852521 — SATLEC PROPHY UNIT PU 3055 (July 31, 1985)
  • K852524 — SATALEC SERVOTORQUE S2 SX2 (July 31, 1985)
  • K832674 — SATELEC PROPHY UNIT PU 2000S (March 16, 1984)
  • K832664 — SATELEC SUPRASSON PIEZOMATIC P2 (March 16, 1984)
  • K832665 — SATELEC SUPRASSON SP 3055 (October 19, 1983)
  • K832673 — SATELEC PROPHY UNIT PU-2000 (October 19, 1983)

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