The following data is part of a premarket notification filed by Biocore Medical Technologies, Inc. with the FDA for Collatek Sheet.
| Device ID | K012995 |
| 510k Number | K012995 |
| Device Name: | COLLATEK SHEET |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | BIOCORE MEDICAL TECHNOLOGIES, INC. 11800 TECH ROAD, SUITE # 240 Silver Spring, MD 20904 -1908 |
| Contact | Ajay Kumar |
| Correspondent | Ajay Kumar BIOCORE MEDICAL TECHNOLOGIES, INC. 11800 TECH ROAD, SUITE # 240 Silver Spring, MD 20904 -1908 |
| Product Code | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-06 |
| Decision Date | 2001-10-25 |
| Summary: | summary |