The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Mccain Instrument Tmj/sm. Joint Arthroscopic Surg.
| Device ID | K874911 |
| 510k Number | K874911 |
| Device Name: | MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURG |
| Classification | Arthroscope |
| Applicant | WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Contact | Debra A Powers |
| Correspondent | Debra A Powers WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-02 |
| Decision Date | 1988-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540134882 | K874911 | 000 |
| 04546540134875 | K874911 | 000 |