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FDA 510(k)

COMFORT PLUS BREAST SHELLS

K-Number: K935341 · 1994-01-21

ApplicantMarshall Baby Products
Decision Date1994-01-21
Product CodeHFS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

COMFORT PLUS BREAST SHELLS is the device name listed in this FDA 510(k) record. The listed applicant is Marshall Baby Products. It received FDA 510(k) clearance on 1994-01-21 under 510(k) number K935341. The device is classified under product code HFS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMFORT PLUS BREAST SHELLS?

COMFORT PLUS BREAST SHELLS is a medical device that received FDA 510(k) clearance on 1994-01-21. The listed applicant is Marshall Baby Products. The 510(k) number is K935341.

When did COMFORT PLUS BREAST SHELLS receive FDA 510(k) clearance?

COMFORT PLUS BREAST SHELLS received FDA 510(k) clearance on 1994-01-21, under 510(k) number K935341.

Who is the listed applicant for COMFORT PLUS BREAST SHELLS?

The FDA 510(k) record lists Marshall Baby Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMFORT PLUS BREAST SHELLS?

The FDA product code for COMFORT PLUS BREAST SHELLS is HFS.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Marshall Baby Products 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.

K935340COMFORT PLUS NIPPLE SHIELDS

Related Devices (Code: HFS)

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.

K944177BREAST SHELLO'Donnell, Byrne & WilliamsK944117AVENT NIPPLE SHIELDAvent America, Inc.K935340COMFORT PLUS NIPPLE SHIELDSMarshall Baby ProductsK930238BREAST LEAKAGE INHIBITOR SYSTEM: BREAST SHIELDSProlac, Inc.K923577BREAST SHELLSMedela, Inc.K864176GENTLE FEELMali, 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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