The following data is part of a premarket notification filed by Southwest Medical Mfg., Inc. with the FDA for E-z Clamp#1 And#2.
| Device ID | K922243 |
| 510k Number | K922243 |
| Device Name: | E-Z CLAMP#1 AND#2 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | SOUTHWEST MEDICAL MFG., INC. P.O. BOX 71261 Marietta, GA 30007 |
| Contact | Michael C Sibley |
| Correspondent | Michael C Sibley SOUTHWEST MEDICAL MFG., INC. P.O. BOX 71261 Marietta, GA 30007 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-13 |
| Decision Date | 1992-07-14 |