The following data is part of a premarket notification filed by Snowden-pencer with the FDA for Snowden-pencer Insufflator Tubing Set.
Device ID | K913835 |
510k Number | K913835 |
Device Name: | SNOWDEN-PENCER INSUFFLATOR TUBING 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 | 1991-08-26 |
Decision Date | 1991-11-07 |