The following data is part of a premarket notification filed by Mtp Medical Technical Promotion Gmbh with the FDA for Unidrive Ii Plus Disposable Tubing Set.
| Device ID | K021811 |
| 510k Number | K021811 |
| Device Name: | UNIDRIVE II PLUS DISPOSABLE TUBING SET |
| Classification | Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece |
| Applicant | MTP MEDICAL TECHNICAL PROMOTION GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Contact | James A Lee |
| Correspondent | James A Lee MTP MEDICAL TECHNICAL PROMOTION GMBH 600 CORPORATE POINTE Culver City, CA 90230 |
| Product Code | ERL |
| CFR Regulation Number | 874.4250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-03 |
| Decision Date | 2002-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048438001042 | K021811 | 000 |