The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Manu/surg Inst/access Wuerzburg Tit Mini Bone Plat.
Device ID | K854887 |
510k Number | K854887 |
Device Name: | MANU/SURG INST/ACCESS WUERZBURG TIT MINI BONE PLAT |
Classification | Forceps, Rongeur, Surgical |
Applicant | WALTER LORENZ SURGICAL, INC. ADVANCED BIOSEARCH ASSOCIATES 1700 ROCKVILLE PIKE SUITE 320 Rockville, MD 20852 |
Contact | Joel Faden |
Correspondent | Joel Faden WALTER LORENZ SURGICAL, INC. ADVANCED BIOSEARCH ASSOCIATES 1700 ROCKVILLE PIKE SUITE 320 Rockville, MD 20852 |
Product Code | EMH |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-06 |
Decision Date | 1986-02-28 |