The following data is part of a premarket notification filed by Shinchang Medical Co., Ltd. with the FDA for Sc Profi Fine Pen Needle, Models; 5mm, 8mm, 12.7mm (28g, 29g, 30g, 31g).
| Device ID | K070988 |
| 510k Number | K070988 |
| Device Name: | SC PROFI FINE PEN NEEDLE, MODELS; 5MM, 8MM, 12.7MM (28G, 29G, 30G, 31G) |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SHINCHANG MEDICAL CO., LTD. 3762 SOUTH 150 EAST Salt Lake City, UT 84115 |
| Contact | Jan J Frank |
| Correspondent | Jan J Frank SHINCHANG MEDICAL CO., LTD. 3762 SOUTH 150 EAST Salt Lake City, UT 84115 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-06 |
| Decision Date | 2007-08-23 |
| Summary: | summary |