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Biosculptor Corporation

Hialeah, FL, US

BIOSCULPTOR CORPORATION appears in FDA device records in Hialeah, FL. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Biosculptor Corporation in 2009.

Clearances by year, as a table
510(k) clearance decisions for Biosculptor Corporation, by decision year
YearClearances
20091
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K081787CAMLAB CRANIAL ORTHOSIS HELMETOANSubstantially Equivalent

Registered establishments

FDA registered establishments for Biosculptor Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
10005607721000560772BIOSCULPTOR CORPORATION2480 W 82nd St Unit 1, Hialeah, FL 33016 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain