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510(k) K852525

SATALEC PIEZOTEC by Spelna, Inc. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1986
Date Received
June 14, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type

Other clearances by Spelna, Inc.

  • 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)
  • K820256 — MEDILAC #SR4 & SR 40 (June 25, 1982)

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