The following data is part of a premarket notification filed by Bemis Mfg. Co. with the FDA for No-pokes Needle Safety Device.
Device ID | K020921 |
510k Number | K020921 |
Device Name: | NO-POKES NEEDLE SAFETY DEVICE |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | BEMIS MFG. CO. 300 MILL ST. Sheboygan Falls, WI 53085 |
Contact | John B Howell |
Correspondent | John B Howell BEMIS MFG. CO. 300 MILL ST. Sheboygan Falls, WI 53085 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-03-21 |
Decision Date | 2002-07-11 |