The following data is part of a premarket notification filed by Snowden-pencer with the FDA for Endo I/a Probe.
Device ID | K924149 |
510k Number | K924149 |
Device Name: | ENDO I/A PROBE |
Classification | Laparoscope, General & Plastic Surgery |
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 | GCJ |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-18 |
Decision Date | 1993-01-26 |