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FDA 510(k)

DRYTIME FOR BLADDER CONTROL SILENT

K-Number: K962416 · 1996-07-22

ApplicantBio-Systems Research
Decision Date1996-07-22
Product CodeKPN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DRYTIME FOR BLADDER CONTROL SILENT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Systems Research. It received FDA 510(k) clearance on 1996-07-22 under 510(k) number K962416. The device is classified under product code KPN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRYTIME FOR BLADDER CONTROL SILENT?

DRYTIME FOR BLADDER CONTROL SILENT is a medical device that received FDA 510(k) clearance on 1996-07-22. The listed applicant is Bio-Systems Research. The 510(k) number is K962416.

When did DRYTIME FOR BLADDER CONTROL SILENT receive FDA 510(k) clearance?

DRYTIME FOR BLADDER CONTROL SILENT received FDA 510(k) clearance on 1996-07-22, under 510(k) number K962416.

Who is the listed applicant for DRYTIME FOR BLADDER CONTROL SILENT?

The FDA 510(k) record lists Bio-Systems Research as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRYTIME FOR BLADDER CONTROL SILENT?

The FDA product code for DRYTIME FOR BLADDER CONTROL SILENT is KPN.

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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Other records listing Bio-Systems Research 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.

K933745PERMAGEN UNIVERSAL BONDING RESIN

Related Devices (Code: KPN)

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.

K130951SIMSimavita Pty LimitedK971442HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5Humed, Inc.K971855POTTY PAL AND FOREVER-DRYDigital Applications, Inc.K962770UROSURGE ACUTRAINERPrinceton Regulatory Assoc.K955338DRYTIME FOR POTTY TRAININGHealth Sense Intl., Inc.K943559REMOTE A'LERTHealth Sense Intl., Inc.

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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