The following data is part of a premarket notification filed by Snowden-pencer with the FDA for Snowden-pencer High Flow Insufflator, Sp/88-9700.
Device ID | K920986 |
510k Number | K920986 |
Device Name: | SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700 |
Classification | Insufflator, Laparoscopic |
Applicant | SNOWDEN-PENCER 2058 KILMAN DR. Tucker, GA 30084 |
Contact | Black, Iii |
Correspondent | Black, Iii 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 | 1992-03-02 |
Decision Date | 1992-06-04 |