FDA 510(k)

60 ML RESERVOIR BAG, ITEM #200

K-Number: K875155 · 1988-02-16

Decision Date1988-02-16

Product CodeKPE

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

60 ML RESERVOIR BAG, ITEM #200 is the device name listed in this FDA 510(k) record. The listed applicant is Prn Services, Inc.. It received FDA 510(k) clearance on 1988-02-16 under 510(k) number K875155. The device is classified under product code KPE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 60 ML RESERVOIR BAG, ITEM #200?

60 ML RESERVOIR BAG, ITEM #200 is a medical device that received FDA 510(k) clearance on 1988-02-16. The listed applicant is Prn Services, Inc.. The 510(k) number is K875155.

When did 60 ML RESERVOIR BAG, ITEM #200 receive FDA 510(k) clearance?

60 ML RESERVOIR BAG, ITEM #200 received FDA 510(k) clearance on 1988-02-16, under 510(k) number K875155.

Who is the listed applicant for 60 ML RESERVOIR BAG, ITEM #200?

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

What is the FDA product code for 60 ML RESERVOIR BAG, ITEM #200?

The FDA product code for 60 ML RESERVOIR BAG, ITEM #200 is KPE.

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Related Devices (Code: KPE)

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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.