The following data is part of a premarket notification filed by Symtex Healthcare Corp. with the FDA for Symtex Gauze Pads (1's) And Symtex Gauze Sponges Sterile 2's And Sterile 10's.
| Device ID | K991215 |
| 510k Number | K991215 |
| Device Name: | SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S |
| Classification | Gauze/sponge, Internal |
| Applicant | SYMTEX HEALTHCARE CORP. 783 PINEFALLS AVE. Walnut, CA 91789 |
| Contact | Richard S Wang |
| Correspondent | Richard S Wang SYMTEX HEALTHCARE CORP. 783 PINEFALLS AVE. Walnut, CA 91789 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-09 |
| Decision Date | 1999-06-11 |