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FDA 510(k)

SATELEC SUPRASSON SP 3055

K-Number: K832665 · 1983-10-19

ApplicantSpelna, Inc.
Decision Date1983-10-19
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SATELEC SUPRASSON SP 3055 is the device name listed in this FDA 510(k) record. The listed applicant is Spelna, Inc.. It received FDA 510(k) clearance on 1983-10-19 under 510(k) number K832665. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SATELEC SUPRASSON SP 3055?

SATELEC SUPRASSON SP 3055 is a medical device that received FDA 510(k) clearance on 1983-10-19. The listed applicant is Spelna, Inc.. The 510(k) number is K832665.

When did SATELEC SUPRASSON SP 3055 receive FDA 510(k) clearance?

SATELEC SUPRASSON SP 3055 received FDA 510(k) clearance on 1983-10-19, under 510(k) number K832665.

Who is the listed applicant for SATELEC SUPRASSON SP 3055?

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 SATELEC SUPRASSON SP 3055?

The FDA product code for SATELEC SUPRASSON SP 3055 is ELC.

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Other records listing Spelna, Inc. as applicant

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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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