The following data is part of a premarket notification filed by Safe-tec Clinical Products, Inc. with the FDA for Safe-tec Capillary Blood Collection Tube.
| Device ID | K884623 |
| 510k Number | K884623 |
| Device Name: | SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE |
| Classification | Tube, Collection, Capillary Blood |
| Applicant | SAFE-TEC CLINICAL PRODUCTS, INC. NORTHAMPTON INDUSTRIAL PARK 163 RAILROAD DRIVE Ivyland, PA 18974 |
| Contact | G Kendrick |
| Correspondent | G Kendrick SAFE-TEC CLINICAL PRODUCTS, INC. NORTHAMPTON INDUSTRIAL PARK 163 RAILROAD DRIVE Ivyland, PA 18974 |
| Product Code | GIO |
| CFR Regulation Number | 864.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-04 |
| Decision Date | 1988-12-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382904203185 | K884623 | 000 |
| 30382904203178 | K884623 | 000 |
| 30382904203161 | K884623 | 000 |
| 30382904203154 | K884623 | 000 |
| 30382904203147 | K884623 | 000 |