The following data is part of a premarket notification filed by Menlo Care, Inc. with the FDA for Intropeel.
| Device ID | K930801 |
| 510k Number | K930801 |
| Device Name: | INTROPEEL |
| Classification | Introducer, Catheter |
| Applicant | MENLO CARE, INC. 1350 WILLOW RD. Menlo Park, CA 94025 -1516 |
| Contact | Thom Lawson |
| Correspondent | Thom Lawson MENLO CARE, INC. 1350 WILLOW RD. Menlo Park, CA 94025 -1516 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-16 |
| Decision Date | 1993-09-22 |