The following data is part of a premarket notification filed by International Medical Devices, Inc. with the FDA for Pre-formed Penile Silicone Block.
| Device ID | K162624 |
| 510k Number | K162624 |
| Device Name: | Pre-Formed Penile Silicone Block |
| Classification | Elastomer, Silicone Block |
| Applicant | INTERNATIONAL MEDICAL DEVICES, INC. 717 NORTH MAPLE DRIVE Beverly Hills, CA 90210 |
| Contact | James Elist |
| Correspondent | Allison Komiyama ACKNOWLEDGE REGULATORY STRATEGIES 2834 HAWTHORN ST. San Diego, CA 92104 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-20 |
| Decision Date | 2017-02-01 |
| Summary: | summary |