The following data is part of a premarket notification filed by Lake Medical Products, Inc. with the FDA for Lake Male External Catheterization Kit.
| Device ID | K902508 |
| 510k Number | K902508 |
| Device Name: | LAKE MALE EXTERNAL CATHETERIZATION KIT |
| Classification | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Applicant | LAKE MEDICAL PRODUCTS, INC. 1145 MOOG DR. St. Louis, MO 63146 |
| Contact | Eli Schachet |
| Correspondent | Eli Schachet LAKE MEDICAL PRODUCTS, INC. 1145 MOOG DR. St. Louis, MO 63146 |
| Product Code | FCM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-05 |
| Decision Date | 1990-08-23 |