The following data is part of a premarket notification filed by General Medical Co. with the FDA for Genesis Insufflating Catheter.
| Device ID | K903669 |
| 510k Number | K903669 |
| Device Name: | GENESIS INSUFFLATING CATHETER |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | GENERAL MEDICAL CO. 400 INTERSTATE N. PKWY. SUITE 650 Atlanta, GA 30339 |
| Contact | John Sellers |
| Correspondent | John Sellers GENERAL MEDICAL CO. 400 INTERSTATE N. PKWY. SUITE 650 Atlanta, GA 30339 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-13 |
| Decision Date | 1990-09-12 |