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FDA 510(k)

PENADAPT 10

K-Number: K000904 · 2000-06-08

ApplicantBuffalo Filter Co., Inc.
Decision Date2000-06-08
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PENADAPT 10 is the device name listed in this FDA 510(k) record. The listed applicant is Buffalo Filter Co., Inc.. It received FDA 510(k) clearance on 2000-06-08 under 510(k) number K000904. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENADAPT 10?

PENADAPT 10 is a medical device that received FDA 510(k) clearance on 2000-06-08. The listed applicant is Buffalo Filter Co., Inc.. The 510(k) number is K000904.

When did PENADAPT 10 receive FDA 510(k) clearance?

PENADAPT 10 received FDA 510(k) clearance on 2000-06-08, under 510(k) number K000904.

Who is the listed applicant for PENADAPT 10?

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

What is the FDA product code for PENADAPT 10?

The FDA product code for PENADAPT 10 is FYD.

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Other records listing Buffalo Filter Co., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K983298BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PFK983333BUFFALO FILTER VIROSAFE HRF- #VSHRFO1K983364BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801K943226BUFFALO FILTER REPLACEMENT FILTER #BSPF030K943227BUFFALO FILTER REPLACEMENT FILTER #BSUCF03K930067BUFFALO FILTER SURGICAL MASK

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Related Devices (Code: FYD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240127PlumeSafe X5 Smoke Management SystemConmed CorporationK2337898Q10 Surclear Smoke Plume Evacuation SystemSurnic CorporationK213068Medline Smoke Evacuation ShroudMedline Industries, Inc.K202944NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemNorthgate Technologies, Inc.K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF SensorMegadyne Medical Products, Inc.K192035EvaQMax Smoke Evacuation SystemBio Protech, Inc.

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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