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FDA 510(k)

ROVENSTEIN FORCEPS

K-Number: K880318 · 1988-03-21

ApplicantEastmed Enterprises, Inc.
Decision Date1988-03-21
Product CodeBWB
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ROVENSTEIN FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Eastmed Enterprises, Inc.. It received FDA 510(k) clearance on 1988-03-21 under 510(k) number K880318. The device is classified under product code BWB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROVENSTEIN FORCEPS?

ROVENSTEIN FORCEPS is a medical device that received FDA 510(k) clearance on 1988-03-21. The listed applicant is Eastmed Enterprises, Inc.. The 510(k) number is K880318.

When did ROVENSTEIN FORCEPS receive FDA 510(k) clearance?

ROVENSTEIN FORCEPS received FDA 510(k) clearance on 1988-03-21, under 510(k) number K880318.

Who is the listed applicant for ROVENSTEIN FORCEPS?

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

What is the FDA product code for ROVENSTEIN FORCEPS?

The FDA product code for ROVENSTEIN FORCEPS is BWB.

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Other records listing Eastmed Enterprises, 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.

K922019LARYNGOSCOPE RIGIDK921128ENDOTRACHEAL TUBE STYLETK914741AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIEDK903618ROBERTAZZI NASOPHARYNGEAL AIRWAYK901489MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE)K890342AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES)

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Related Devices (Code: BWB)

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.

K884584TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADSEastmed Enterprises, Inc.K880319MAGILL FORCEPSEastmed Enterprises, Inc.K840313CAT. 9 ANESTHESIOLOGY RESPIRATORY DEVImm Enterprises , Ltd.K834169OP-CON SURGICAL INSTRUMENT #9Imm Enterprises , Ltd.K820451INTRODUCER FOR ENDOTRACHEAL TUBEImed Corp.

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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