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FDA 510(k)

PURITAN FOAM TIP SWAB MODEL 2197

K-Number: K961934 · 1996-07-09

ApplicantHardwood Products Co., LP
Decision Date1996-07-09
Product CodeHHT
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

PURITAN FOAM TIP SWAB MODEL 2197 is the device name listed in this FDA 510(k) record. The listed applicant is Hardwood Products Co., LP. It received FDA 510(k) clearance on 1996-07-09 under 510(k) number K961934. The device is classified under product code HHT. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PURITAN FOAM TIP SWAB MODEL 2197?

PURITAN FOAM TIP SWAB MODEL 2197 is a medical device that received FDA 510(k) clearance on 1996-07-09. The listed applicant is Hardwood Products Co., LP. The 510(k) number is K961934.

When did PURITAN FOAM TIP SWAB MODEL 2197 receive FDA 510(k) clearance?

PURITAN FOAM TIP SWAB MODEL 2197 received FDA 510(k) clearance on 1996-07-09, under 510(k) number K961934.

Who is the listed applicant for PURITAN FOAM TIP SWAB MODEL 2197?

The FDA 510(k) record lists Hardwood Products Co., LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PURITAN FOAM TIP SWAB MODEL 2197?

The FDA product code for PURITAN FOAM TIP SWAB MODEL 2197 is HHT.

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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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