The following data is part of a premarket notification filed by Phoenix Biomedical Corp. with the FDA for Phoenix Ete Tissue Extension System.
| Device ID | K962144 |
| 510k Number | K962144 |
| Device Name: | PHOENIX ETE TISSUE EXTENSION SYSTEM |
| Classification | System, Skin Closure |
| Applicant | PHOENIX BIOMEDICAL CORP. P.O. BOX 80390 Norristown, PA 19403 |
| Contact | Horace J Wilmer |
| Correspondent | Horace J Wilmer PHOENIX BIOMEDICAL CORP. P.O. BOX 80390 Norristown, PA 19403 |
| Product Code | MKY |
| CFR Regulation Number | 878.4320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-03 |
| Decision Date | 1997-01-14 |