FDA 510(k)

NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100

K-Number: K870806 · 1987-03-26

Decision Date1987-03-26

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100 is the device name listed in this FDA 510(k) record. The listed applicant is United Surgical Corp.. It received FDA 510(k) clearance on 1987-03-26 under 510(k) number K870806. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100?

NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100 is a medical device that received FDA 510(k) clearance on 1987-03-26. The listed applicant is United Surgical Corp.. The 510(k) number is K870806.

When did NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100 receive FDA 510(k) clearance?

NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100 received FDA 510(k) clearance on 1987-03-26, under 510(k) number K870806.

Who is the listed applicant for NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100?

The FDA 510(k) record lists United Surgical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100?

The FDA product code for NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100 is HQC.

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Other records listing United Surgical Corp. as applicant

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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.