The following data is part of a premarket notification filed by Unisurge Holding, Inc. with the FDA for Unisurge Interface P.
| Device ID | K972178 |
| 510k Number | K972178 |
| Device Name: | UNISURGE INTERFACE P |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | UNISURGE HOLDING, INC. 6107 OAKBROOK PKWY., SUITE A Norcross, GA 30093 -1716 |
| Contact | Stacie Buttorff |
| Correspondent | Stacie Buttorff UNISURGE HOLDING, INC. 6107 OAKBROOK PKWY., SUITE A Norcross, GA 30093 -1716 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-10 |
| Decision Date | 1997-09-05 |