SATLEC PROPHY UNIT PU 3055— 510(k) K852521

Substantially Equivalent

Spelna, Inc.

FDA 510(k) clearance K852521 for SATLEC PROPHY UNIT PU 3055, Substantially Equivalent on 1985-07-31. Applicant: Spelna, Inc.. Device class: 2.

Clearance details

Applicant: Spelna, Inc.
Product code: Code KOJ
Device class: Class 2
Regulation: 21 CFR 872.6080
Advisory panel: Dental
Date received: 1985-06-14
Decision date: 1985-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fredericksburg, VA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Spelna, Inc.

K852525 — SATALEC PIEZOTEC1986-01-30
K852527 — SATALEC SEPTOSONIC SC 80/SC 1201986-01-03
K852522 — SATALEC SERVOTOME1985-12-27
K853200 — 5X2 SATALEC CHIROPODY CASE1985-10-18
K852524 — SATALEC SERVOTORQUE S2 SX21985-07-31

Data sourced from openFDA. This site is unofficial and independent of the FDA.