FDA Registration Active 🇺🇸 United States

PALACOS® MV pro

Reg #: 3013186738 · FEI: 3013186738 · Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3

Registration Details

Registration Name
Heraeus Medical LLC
Registration Number
3013186738
FEI Number
3013186738
Status
Active
Expiry Year
2025
Initial Importer
Yes
Address
Township Line Road 770, Suite 300
City
Yardley
State
PA
ZIP
19067
Country
US

Regulatory Submissions

510(k) Number
K213812

Owner / Operator

Firm Name
Heraeus Medical GmbH
Operator Number
10048423
Address
Philipp-Reis-Str. 8/13
City
Wehrheim
State
Hesse
Postal Code
61273
Country
DE
Correspondent
Benjamin Hagedorn

Products

Device Name Product Code
Bone Cement LOD
Dispenser, Cement KIH
Mixer, Cement, For Clinical Use JDZ

Proprietary Names

PALACOS® MV pro

Establishment Types

Complaint File Establishment per 21 CFR 820.198