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FDA 510(k)

ROSEALAE

K-Number: K782001 · 1978-12-07

ApplicantAsmb
Decision Date1978-12-07
Product CodeKME
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ROSEALAE is the device name listed in this FDA 510(k) record. The listed applicant is Asmb. It received FDA 510(k) clearance on 1978-12-07 under 510(k) number K782001. The device is classified under product code KME. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROSEALAE?

ROSEALAE is a medical device that received FDA 510(k) clearance on 1978-12-07. The listed applicant is Asmb. The 510(k) number is K782001.

When did ROSEALAE receive FDA 510(k) clearance?

ROSEALAE received FDA 510(k) clearance on 1978-12-07, under 510(k) number K782001.

Who is the listed applicant for ROSEALAE?

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

What is the FDA product code for ROSEALAE?

The FDA product code for ROSEALAE is KME.

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Related Devices (Code: KME)

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.

K042145READY-HEAT BLANKETTechtrade, LLCK944953OREX MEDICAL BEDDINGThantex Specialties, Inc.K933636DISPOSE-A-SHEETBelmac Healthcare Corp.K932539DOCTOR DOWN --RESCUE WRAPThree Dog DownK922143AMERICAN BURN SHEETAmerican Silk Sutures, Inc.K915303FOIL BABY BUNTINGGam Industries, 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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