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FDA 510(k)

SUPER DONUT

K-Number: K822650 · 1982-09-30

ApplicantAlimed, Inc.
Decision Date1982-09-30
Product CodeKME
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SUPER DONUT is the device name listed in this FDA 510(k) record. The listed applicant is Alimed, Inc.. It received FDA 510(k) clearance on 1982-09-30 under 510(k) number K822650. 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 SUPER DONUT?

SUPER DONUT is a medical device that received FDA 510(k) clearance on 1982-09-30. The listed applicant is Alimed, Inc.. The 510(k) number is K822650.

When did SUPER DONUT receive FDA 510(k) clearance?

SUPER DONUT received FDA 510(k) clearance on 1982-09-30, under 510(k) number K822650.

Who is the listed applicant for SUPER DONUT?

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

What is the FDA product code for SUPER DONUT?

The FDA product code for SUPER DONUT is KME.

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Other records listing Alimed, 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.

K963527UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPSK963528ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES)K963526STRAP WEDGEK920487MINI VIBRATORK840156PROTECTA COAT SPONGESK822651TOTAL FINGER FLEXION SPLINT

View all 11 devices →

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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