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FDA 510(k)

PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167

K-Number: K960949 · 1996-04-19

ApplicantBristol-Myers Squibb
Decision Date1996-04-19
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 is the device name listed in this FDA 510(k) record. The listed applicant is Bristol-Myers Squibb. It received FDA 510(k) clearance on 1996-04-19 under 510(k) number K960949. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167?

PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 is a medical device that received FDA 510(k) clearance on 1996-04-19. The listed applicant is Bristol-Myers Squibb. The 510(k) number is K960949.

When did PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 receive FDA 510(k) clearance?

PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 received FDA 510(k) clearance on 1996-04-19, under 510(k) number K960949.

Who is the listed applicant for PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167?

The FDA 510(k) record lists Bristol-Myers Squibb as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167?

The FDA product code for PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 is KNX.

Related Clinical Trials

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.

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Related Devices (Code: KNX)

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.

K110518IBAGFuture Path Medical, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, 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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