The following data is part of a premarket notification filed by Georgia Medical Products, Inc. with the FDA for Tube Grip.
| Device ID | K922404 |
| 510k Number | K922404 |
| Device Name: | TUBE GRIP |
| Classification | Accessory Equipment, Cardiopulmonary Bypass |
| Applicant | GEORGIA MEDICAL PRODUCTS, INC. 4390 BISHOP LAKE RD. Marietta, GA 30062 |
| Contact | Steven L Downing |
| Correspondent | Steven L Downing GEORGIA MEDICAL PRODUCTS, INC. 4390 BISHOP LAKE RD. Marietta, GA 30062 |
| Product Code | KRI |
| CFR Regulation Number | 870.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-21 |
| Decision Date | 1992-11-23 |