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FDA 510(k)

AUTO SASH (TM)

K-Number: K910695 · 1991-03-21

ApplicantBlock Medical, Inc.
Decision Date1991-03-21
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AUTO SASH (TM) is the device name listed in this FDA 510(k) record. The listed applicant is Block Medical, Inc.. It received FDA 510(k) clearance on 1991-03-21 under 510(k) number K910695. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTO SASH (TM)?

AUTO SASH (TM) is a medical device that received FDA 510(k) clearance on 1991-03-21. The listed applicant is Block Medical, Inc.. The 510(k) number is K910695.

When did AUTO SASH (TM) receive FDA 510(k) clearance?

AUTO SASH (TM) received FDA 510(k) clearance on 1991-03-21, under 510(k) number K910695.

Who is the listed applicant for AUTO SASH (TM)?

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

What is the FDA product code for AUTO SASH (TM)?

The FDA product code for AUTO SASH (TM) is FPA.

Other records listing Block Medical, Inc. 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.

K944692C-SERIES HOMEPUMPK940117MID-500K934551VERIFUSE AMBULATORY PUMPK935236FLOW CONTROLLING EXTENSION SETK932740HOMEPUMP NSFK904663AUTO SASH (TM)

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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