The following data is part of a premarket notification filed by Coloplast Corp. with the FDA for Personally(tm), Model 241 Sizes 0-12,left & Right.
| Device ID | K864786 |
| 510k Number | K864786 |
| Device Name: | PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT |
| Classification | Material, External Aesthetic Restoration, Used With Adhesive |
| Applicant | COLOPLAST CORP. 2150 NEW MARKET PARKWAY, SUITE 116 Marietta, GA 30067 |
| Contact | Thomas B Taylor |
| Correspondent | Thomas B Taylor COLOPLAST CORP. 2150 NEW MARKET PARKWAY, SUITE 116 Marietta, GA 30067 |
| Product Code | GBI |
| CFR Regulation Number | 878.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-08 |
| Decision Date | 1987-01-08 |