The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Lyoplant Dura Substitute(various).
Device ID | K970851 |
510k Number | K970851 |
Device Name: | LYOPLANT DURA SUBSTITUTE(VARIOUS) |
Classification | Dura Substitute |
Applicant | AESCULAP, INC. 1000 GATEWAY BLVD. South San Francisco, CA 94080 |
Contact | Victoria Mackinnon |
Correspondent | Victoria Mackinnon AESCULAP, INC. 1000 GATEWAY BLVD. South San Francisco, CA 94080 |
Product Code | GXQ |
CFR Regulation Number | 882.5910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-03-07 |
Decision Date | 1997-12-09 |
Summary: | summary |