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Secured Ortho Manufacturing of America, LLC

Deer Park, NY, US

SECURED ORTHO MANUFACTURING OF AMERICA, LLC appears in FDA device records in Deer Park, NY. 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 Secured Ortho Manufacturing of America, LLC in 2021.

Clearances by year, as a table
510(k) clearance decisions for Secured Ortho Manufacturing of America, LLC, by decision year
YearClearances
20211
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K203101Secure Wear USA Surgical Face MaskFXXSubstantially Equivalent

Registered establishments

FDA registered establishments for Secured Ortho Manufacturing of America, LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30146585413014658541SECURED ORTHO MANUFACTURING OF AMERICA, LLC28 West Jefryn Boulevard, Suite C, Deer Park, NY 11729 US2026and 10 more, listed in full below

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

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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