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510(k) K853200

5X2 SATALEC CHIROPODY CASE by Spelna, Inc.

K853200 is an FDA 510(k) premarket notification submitted by Spelna, Inc. for the device "5X2 SATALEC CHIROPODY CASE". The FDA issued a decision of Substantially Equivalent on October 18, 1985. Spelna, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1985
Date Received
June 14, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K852521 — SATLEC PROPHY UNIT PU 3055 (July 31, 1985)
  • K852524 — SATALEC SERVOTORQUE S2 SX2 (July 31, 1985)
  • K832664 — SATELEC SUPRASSON PIEZOMATIC P2 (March 16, 1984)
  • K832674 — SATELEC PROPHY UNIT PU 2000S (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)

FDA data resources