The following data is part of a premarket notification filed by Tz Medical, Inc. with the FDA for Ez Hold 1 Lbs., Ez Hold 2 Lbs.
| Device ID | K973132 |
| 510k Number | K973132 |
| Device Name: | EZ HOLD 1 LBS., EZ HOLD 2 LBS |
| Classification | Clamp, Vascular |
| Applicant | TZ MEDICAL, INC. 15858 S.W. UPPER BOONES FERRY RD. Lake Oswego, OR 97035 |
| Contact | Byron Zahler |
| Correspondent | Byron Zahler TZ MEDICAL, INC. 15858 S.W. UPPER BOONES FERRY RD. Lake Oswego, OR 97035 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-21 |
| Decision Date | 1998-01-12 |