The following data is part of a premarket notification filed by Lingeman Medical Products, Inc. with the FDA for The Percutaneous Nephrostolithotomy Drape.
| Device ID | K851675 |
| 510k Number | K851675 |
| Device Name: | THE PERCUTANEOUS NEPHROSTOLITHOTOMY DRAPE |
| Classification | Drape, Urological, Disposable |
| Applicant | LINGEMAN MEDICAL PRODUCTS, INC. 3401 XENIA CIRCLE Indianapolis, IN 46227 |
| Contact | Paul Lingeman |
| Correspondent | Paul Lingeman LINGEMAN MEDICAL PRODUCTS, INC. 3401 XENIA CIRCLE Indianapolis, IN 46227 |
| Product Code | EYY |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-23 |
| Decision Date | 1985-05-14 |