The following data is part of a premarket notification filed by Snowden-pencer with the FDA for Endo I/a Y Set.
| Device ID | K913979 |
| 510k Number | K913979 |
| Device Name: | ENDO I/A Y SET |
| Classification | Insufflator, Laparoscopic |
| Applicant | SNOWDEN-PENCER 2058 KILMAN DR. Tucker, GA 30084 |
| Contact | Norman M Black |
| Correspondent | Norman M Black SNOWDEN-PENCER 2058 KILMAN DR. Tucker, GA 30084 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-06 |
| Decision Date | 1991-11-27 |