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FDA 510(k)

LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE

K-Number: K853708 · 1986-02-14

ApplicantDowns Surgical , Ltd.
Decision Date1986-02-14
Product CodeKAE
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE is the device name listed in this FDA 510(k) record. The listed applicant is Downs Surgical , Ltd.. It received FDA 510(k) clearance on 1986-02-14 under 510(k) number K853708. The device is classified under product code KAE. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE?

LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE is a medical device that received FDA 510(k) clearance on 1986-02-14. The listed applicant is Downs Surgical , Ltd.. The 510(k) number is K853708.

When did LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE receive FDA 510(k) clearance?

LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE received FDA 510(k) clearance on 1986-02-14, under 510(k) number K853708.

Who is the listed applicant for LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE?

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

What is the FDA product code for LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE?

The FDA product code for LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE is KAE.

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Other records listing Downs Surgical , Ltd. 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.

K903750ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-EK903747ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-UK903749ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-UK903748ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-VK900609SHEPPERD STRAIGHT AND CURVED NEEDLESK900616SHEPPERD CUTTING FORCEPS

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Related Devices (Code: KAE)

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.

K85177519-790 TO 19-1042 DRESSING/SPONGE FORCEPSArtiberiaK85179441-180 TO 41-246 VARIOUS NASAL FORCEPSArtiberiaK85179541-250 TO 41-282 VARIOUS NASAL CUTTING FORCEPSArtiberiaK833608GOLD ALLIGATOR FORCEPSMicrotek Medical, Inc.K833607MCGEE FORCEPSMicrotek Medical, Inc.K833605CUPPED FORCEPSMicrotek Medical, 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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