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FDA 510(k)

SATALEC SEPTOSONIC SC 80/SC 120

K-Number: K852527 · 1986-01-03

ApplicantSpelna, Inc.
Decision Date1986-01-03
Product CodeFLG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SATALEC SEPTOSONIC SC 80/SC 120 is the device name listed in this FDA 510(k) record. The listed applicant is Spelna, Inc.. It received FDA 510(k) clearance on 1986-01-03 under 510(k) number K852527. The device is classified under product code FLG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SATALEC SEPTOSONIC SC 80/SC 120?

SATALEC SEPTOSONIC SC 80/SC 120 is a medical device that received FDA 510(k) clearance on 1986-01-03. The listed applicant is Spelna, Inc.. The 510(k) number is K852527.

When did SATALEC SEPTOSONIC SC 80/SC 120 receive FDA 510(k) clearance?

SATALEC SEPTOSONIC SC 80/SC 120 received FDA 510(k) clearance on 1986-01-03, under 510(k) number K852527.

Who is the listed applicant for SATALEC SEPTOSONIC SC 80/SC 120?

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 SEPTOSONIC SC 80/SC 120?

The FDA product code for SATALEC SEPTOSONIC SC 80/SC 120 is FLG.

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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 PIEZOTECK852522SATALEC SERVOTOMEK8532005X2 SATALEC CHIROPODY CASEK852521SATLEC PROPHY UNIT PU 3055K852524SATALEC SERVOTORQUE S2 SX2K832664SATELEC SUPRASSON PIEZOMATIC P2

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Related Devices (Code: FLG)

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.

K944950KLENZYMECalgon Corp.K944494ALSA-KLENZCalgon Vestal Div.K944033BILL EVANS-KLENZCalgon Vestal Div.K940263NPH-KLENZCalgon Corp.K941163MON-KLENZCalgon Vestal Div.K935063INSTRU KLENZCalgon Corp.

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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