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FDA 510(k)

TABLE ACCESSORIES, OPERATING ROOM

K-Number: K852332 · 1985-07-02

ApplicantScholten Surgical Instruments, Inc.
Decision Date1985-07-02
Product CodeBWN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TABLE ACCESSORIES, OPERATING ROOM is the device name listed in this FDA 510(k) record. The listed applicant is Scholten Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1985-07-02 under 510(k) number K852332. The device is classified under product code BWN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TABLE ACCESSORIES, OPERATING ROOM?

TABLE ACCESSORIES, OPERATING ROOM is a medical device that received FDA 510(k) clearance on 1985-07-02. The listed applicant is Scholten Surgical Instruments, Inc.. The 510(k) number is K852332.

When did TABLE ACCESSORIES, OPERATING ROOM receive FDA 510(k) clearance?

TABLE ACCESSORIES, OPERATING ROOM received FDA 510(k) clearance on 1985-07-02, under 510(k) number K852332.

Who is the listed applicant for TABLE ACCESSORIES, OPERATING ROOM?

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

What is the FDA product code for TABLE ACCESSORIES, OPERATING ROOM?

The FDA product code for TABLE ACCESSORIES, OPERATING ROOM is BWN.

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Other records listing Scholten Surgical Instruments, 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.

K072051NOVATOME, MODEL: SU101-50K900405SCHOLTEN FRAMEK852331SYS, ANGIOGRAPHIC, SINGLE-OR BI-PLANE RADIOGRAPHICK852119TEMPORARY PACEMAKER GROUND WIREK852120FORCEPS, BIOPSY(NON RIGID)K852330RETRACTOR, SURGICAL

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Related Devices (Code: BWN)

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K942699AIRFRAME SURGICAL DRAPE SUPPORTAlpha Surgical, Inc.K935441INFINITECH BREATH EZInfinitech, Inc.K925005ISI SELF-SUPPORTING ARMInstrumentation Specialties, Inc.K922288HOLDER, PEDIATRIC POSITIONYamashita and Hemsley Business TrustK910783SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604MSmith & Nephew Equipment GroupK902865BAUMER SURGICAL TABLESds Dental, 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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