The following data is part of a premarket notification filed by Edge Systems Corp. with the FDA for Edge Systems Sterile Tubing.
| Device ID | K990748 |
| 510k Number | K990748 |
| Device Name: | EDGE SYSTEMS STERILE TUBING |
| Classification | Powered Laser Surgical Instrument |
| Applicant | EDGE SYSTEMS CORP. 30001 GOLDENLANTERN #334 Laguna Niguel, CA 92677 |
| Contact | Gary Mocnik |
| Correspondent | Gary Mocnik EDGE SYSTEMS CORP. 30001 GOLDENLANTERN #334 Laguna Niguel, CA 92677 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-08 |
| Decision Date | 1999-05-04 |