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FDA 510(k)

STAND, OPERATING ROOM

K-Number: K852329 · 1985-06-14

ApplicantScholten Surgical Instruments, Inc.
Decision Date1985-06-14
Product CodeFOX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STAND, 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 1985-06-14 under 510(k) number K852329. The device is classified under product code FOX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAND, OPERATING ROOM?

STAND, OPERATING ROOM is a medical device that received FDA 510(k) clearance on 1985-06-14. The listed applicant is Scholten Surgical Instruments, Inc.. The 510(k) number is K852329.

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

STAND, OPERATING ROOM received FDA 510(k) clearance on 1985-06-14, under 510(k) number K852329.

Who is the listed applicant for STAND, 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 STAND, OPERATING ROOM?

The FDA product code for STAND, OPERATING ROOM is FOX.

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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 WIREK852332TABLE ACCESSORIES, OPERATING ROOMK852120FORCEPS, BIOPSY(NON RIGID)

View all 8 devices →

Related Devices (Code: FOX)

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.

K980336IV STANDSClinton Industries, Inc.K964782MEDRAD CONTRAST HOLDERMedrad, Inc.K961470PORT-A-POLEPrins Medical Ind., Inc.K960027HIGH VOLUME I.V. & IRRIGATION TOWERAllen Medical Systems, Inc.K952196IV POLE/STANDValentine Intl. , Ltd.K950367IV SHUTTLEEquipment Concepts, 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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