The following data is part of a premarket notification filed by Phoenix Surgical Products, Inc. with the FDA for Surgi-spray O.r. Irrigation System.
| Device ID | K913568 |
| 510k Number | K913568 |
| Device Name: | SURGI-SPRAY O.R. IRRIGATION SYSTEM |
| Classification | Lavage, Jet |
| Applicant | PHOENIX SURGICAL PRODUCTS, INC. 13260 NORTH 94TH DRIVE, #300 Phoenix, AZ 85381 |
| Contact | William Resse |
| Correspondent | William Resse PHOENIX SURGICAL PRODUCTS, INC. 13260 NORTH 94TH DRIVE, #300 Phoenix, AZ 85381 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-09 |
| Decision Date | 1991-11-01 |