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FDA 510(k)

PADIATRY PACK & SHEET WITH FABRIC 450

K-Number: K790224 · 1979-02-16

ApplicantSurgikos, Inc.
Decision Date1979-02-16
Product CodeKKX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PADIATRY PACK & SHEET WITH FABRIC 450 is the device name listed in this FDA 510(k) record. The listed applicant is Surgikos, Inc.. It received FDA 510(k) clearance on 1979-02-16 under 510(k) number K790224. 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 PADIATRY PACK & SHEET WITH FABRIC 450?

PADIATRY PACK & SHEET WITH FABRIC 450 is a medical device that received FDA 510(k) clearance on 1979-02-16. The listed applicant is Surgikos, Inc.. The 510(k) number is K790224.

When did PADIATRY PACK & SHEET WITH FABRIC 450 receive FDA 510(k) clearance?

PADIATRY PACK & SHEET WITH FABRIC 450 received FDA 510(k) clearance on 1979-02-16, under 510(k) number K790224.

Who is the listed applicant for PADIATRY PACK & SHEET WITH FABRIC 450?

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

What is the FDA product code for PADIATRY PACK & SHEET WITH FABRIC 450?

The FDA product code for PADIATRY PACK & SHEET WITH FABRIC 450 is KKX.

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Other records listing Surgikos, 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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