The following data is part of a premarket notification filed by Crystal Medical Products, Inc. with the FDA for La Diffusion Technique, Kty Cm-10 Breast Pump.
| Device ID | K861513 |
| 510k Number | K861513 |
| Device Name: | LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMP |
| Classification | Pump, Breast, Powered |
| Applicant | CRYSTAL MEDICAL PRODUCTS, INC. 118 BARRINGTON COMMONS PLAZA SUITE 240 Barrington, IL 60010 |
| Contact | Frait, Jr |
| Correspondent | Frait, Jr CRYSTAL MEDICAL PRODUCTS, INC. 118 BARRINGTON COMMONS PLAZA SUITE 240 Barrington, IL 60010 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-23 |
| Decision Date | 1986-08-08 |