The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Pectus Support Bar, Titanium; Lorenz Pectus Support Bar Stabilizer, Titanium.
Device ID | K061384 |
510k Number | K061384 |
Device Name: | LORENZ PECTUS SUPPORT BAR, TITANIUM; LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM |
Classification | Plate, Fixation, Bone |
Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
Contact | Kim Reed |
Correspondent | Kim Reed WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-05-18 |
Decision Date | 2006-06-06 |
Summary: | summary |