The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Aesculap Neuro Patties.
Device ID | K062406 |
510k Number | K062406 |
Device Name: | AESCULAP NEURO PATTIES |
Classification | Neurosurgical Paddie |
Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
Contact | Lisa M Boyle |
Correspondent | Lisa M Boyle AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
Product Code | HBA |
CFR Regulation Number | 882.4700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-17 |
Decision Date | 2006-09-15 |
Summary: | summary |