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FDA 510(k)

5X2 SATALEC CHIROPODY CASE

K-Number: K853200 · 1985-10-18

ApplicantSpelna, Inc.
Decision Date1985-10-18
Product Code
DecisionSubstantially Equivalent

Device Summary

5X2 SATALEC CHIROPODY CASE is the device name listed in this FDA 510(k) record. The listed applicant is Spelna, Inc.. It received FDA 510(k) clearance on 1985-10-18 under 510(k) number K853200. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 5X2 SATALEC CHIROPODY CASE?

5X2 SATALEC CHIROPODY CASE is a medical device that received FDA 510(k) clearance on 1985-10-18. The listed applicant is Spelna, Inc.. The 510(k) number is K853200.

When did 5X2 SATALEC CHIROPODY CASE receive FDA 510(k) clearance?

5X2 SATALEC CHIROPODY CASE received FDA 510(k) clearance on 1985-10-18, under 510(k) number K853200.

Who is the listed applicant for 5X2 SATALEC CHIROPODY CASE?

The FDA 510(k) record lists Spelna, Inc. as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Spelna, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K852525SATALEC PIEZOTECK852527SATALEC SEPTOSONIC SC 80/SC 120K852522SATALEC SERVOTOMEK852521SATLEC PROPHY UNIT PU 3055K852524SATALEC SERVOTORQUE S2 SX2K832664SATELEC SUPRASSON PIEZOMATIC P2

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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