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FDA 510(k)

RUTTER SUPRA STOMAL STENTS

K-Number: K091135 · 2009-09-14

ApplicantBoston Medical Products, Inc.
Decision Date2009-09-14
Product CodeFWN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RUTTER SUPRA STOMAL STENTS is the device name listed in this FDA 510(k) record. The listed applicant is Boston Medical Products, Inc.. It received FDA 510(k) clearance on 2009-09-14 under 510(k) number K091135. The device is classified under product code FWN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUTTER SUPRA STOMAL STENTS?

RUTTER SUPRA STOMAL STENTS is a medical device that received FDA 510(k) clearance on 2009-09-14. The listed applicant is Boston Medical Products, Inc.. The 510(k) number is K091135.

When did RUTTER SUPRA STOMAL STENTS receive FDA 510(k) clearance?

RUTTER SUPRA STOMAL STENTS received FDA 510(k) clearance on 2009-09-14, under 510(k) number K091135.

Who is the listed applicant for RUTTER SUPRA STOMAL STENTS?

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

What is the FDA product code for RUTTER SUPRA STOMAL STENTS?

The FDA product code for RUTTER SUPRA STOMAL STENTS is FWN.

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Related Devices (Code: FWN)

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.

K000154ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1E. Benson Hood Lab, Inc.K962693MONTGOMERY RADIOPAQUE LARYNGEAL KEELBoston Medical Products, Inc.K896667LORENZ STENTWalter Lorenz Surgical, Inc.K884810SILICONE LARYNGEAL STENTHood LaboratoriesK864936'EXMOOR' DAS GUPTA LARYNGEAL KEELExmoor Plastics , Ltd.K853726LARYNGEALHood Laboratories

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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