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 |