The following data is part of a premarket notification filed by Snowden-pencer with the FDA for Reusable Laparoscopic Instruments.
Device ID | K930667 |
510k Number | K930667 |
Device Name: | REUSABLE LAPAROSCOPIC INSTRUMENTS |
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 | 1993-02-09 |
Decision Date | 1994-05-16 |