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FDA 510(k)

SENGEWALD CATALOG NUMBER 55 66 01

K-Number: K863323 · 1986-10-29

ApplicantSengewald/USA, Inc.
Decision Date1986-10-29
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SENGEWALD CATALOG NUMBER 55 66 01 is the device name listed in this FDA 510(k) record. The listed applicant is Sengewald/USA, Inc.. It received FDA 510(k) clearance on 1986-10-29 under 510(k) number K863323. The device is classified under product code KKX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENGEWALD CATALOG NUMBER 55 66 01?

SENGEWALD CATALOG NUMBER 55 66 01 is a medical device that received FDA 510(k) clearance on 1986-10-29. The listed applicant is Sengewald/USA, Inc.. The 510(k) number is K863323.

When did SENGEWALD CATALOG NUMBER 55 66 01 receive FDA 510(k) clearance?

SENGEWALD CATALOG NUMBER 55 66 01 received FDA 510(k) clearance on 1986-10-29, under 510(k) number K863323.

Who is the listed applicant for SENGEWALD CATALOG NUMBER 55 66 01?

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

What is the FDA product code for SENGEWALD CATALOG NUMBER 55 66 01?

The FDA product code for SENGEWALD CATALOG NUMBER 55 66 01 is KKX.

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Official Source

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

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