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FDA 510(k)

PLEURAL DRAINAGE SYSTEM #PDS-4300

K-Number: K812224 · 1981-09-09

ApplicantBentley Laboratories, Inc.
Decision Date1981-09-09
Product CodeKDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PLEURAL DRAINAGE SYSTEM #PDS-4300 is the device name listed in this FDA 510(k) record. The listed applicant is Bentley Laboratories, Inc.. It received FDA 510(k) clearance on 1981-09-09 under 510(k) number K812224. The device is classified under product code KDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLEURAL DRAINAGE SYSTEM #PDS-4300?

PLEURAL DRAINAGE SYSTEM #PDS-4300 is a medical device that received FDA 510(k) clearance on 1981-09-09. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K812224.

When did PLEURAL DRAINAGE SYSTEM #PDS-4300 receive FDA 510(k) clearance?

PLEURAL DRAINAGE SYSTEM #PDS-4300 received FDA 510(k) clearance on 1981-09-09, under 510(k) number K812224.

Who is the listed applicant for PLEURAL DRAINAGE SYSTEM #PDS-4300?

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

What is the FDA product code for PLEURAL DRAINAGE SYSTEM #PDS-4300?

The FDA product code for PLEURAL DRAINAGE SYSTEM #PDS-4300 is KDQ.

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Other records listing Bentley Laboratories, Inc. as applicant

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Related Devices (Code: KDQ)

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.

K081718EXPRESS CHEST DRAINAtrium Medical Corp.K062302MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEMMillicore ABK043582OCEAN CHEST DRAINAtrium Medical Corp.K984496ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAINAtrium Medical Corp.K962856PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2-2100, AND S-2200 WITH MODEL S-100 AUTOTRDeknatel, Inc.K961287ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEMRocket Medical Plc

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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