The following data is part of a premarket notification filed by Phoenix Biomedical Corp. with the FDA for Suture Cord.
| Device ID | K953128 |
| 510k Number | K953128 |
| Device Name: | SUTURE CORD |
| Classification | Suture, Nonabsorbable, Synthetic, Polyester |
| Applicant | PHOENIX BIOMEDICAL CORP. 2495 GENERAL ARMSTEAD AVE. P.O. BOX 80390 Valley Forge, PA 19484 |
| Contact | Horace J Wilmer |
| Correspondent | Horace J Wilmer PHOENIX BIOMEDICAL CORP. 2495 GENERAL ARMSTEAD AVE. P.O. BOX 80390 Valley Forge, PA 19484 |
| Product Code | GAS |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-06 |
| Decision Date | 1996-02-09 |