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FDA 510(k)

SATALEC SERVOTOME

K-Number: K852522 · 1985-12-27

ApplicantSpelna, Inc.
Decision Date1985-12-27
Product CodeEKZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SATALEC SERVOTOME is the device name listed in this FDA 510(k) record. The listed applicant is Spelna, Inc.. It received FDA 510(k) clearance on 1985-12-27 under 510(k) number K852522. The device is classified under product code EKZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SATALEC SERVOTOME?

SATALEC SERVOTOME is a medical device that received FDA 510(k) clearance on 1985-12-27. The listed applicant is Spelna, Inc.. The 510(k) number is K852522.

When did SATALEC SERVOTOME receive FDA 510(k) clearance?

SATALEC SERVOTOME received FDA 510(k) clearance on 1985-12-27, under 510(k) number K852522.

Who is the listed applicant for SATALEC SERVOTOME?

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

What is the FDA product code for SATALEC SERVOTOME?

The FDA product code for SATALEC SERVOTOME is EKZ.

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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 120K8532005X2 SATALEC CHIROPODY CASEK852521SATLEC PROPHY UNIT PU 3055K852524SATALEC SERVOTORQUE S2 SX2K832664SATELEC SUPRASSON PIEZOMATIC P2

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Related Devices (Code: EKZ)

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.

K213477Root ZX3J. Morita USA, Inc.K071632PERFECT TISSUE CONTOURING SYSTEM IIColtene/Whaledent, Inc.K063468THE FUGO BLADE FOR DENTISTRYMedisurg , Ltd.K052622MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNITMacan Engineering Co.K050735MC6AMacan Engineering Co.K023672X O ODONTOSURGE 4Xo Care A/S

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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