The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Pectus Support Bar Stabilizer.
Device ID | K981789 |
510k Number | K981789 |
Device Name: | LORENZ PECTUS SUPPORT BAR STABILIZER |
Classification | Plate, Fixation, Bone |
Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
Contact | Diane Preston |
Correspondent | Diane Preston WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-05-20 |
Decision Date | 1998-07-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00841036011093 | K981789 | 000 |