The following data is part of a premarket notification filed by Innovative Medical Technologies, Inc. with the FDA for Quick-draw Capillary Whole Blood Collection System.
| Device ID | K972969 |
| 510k Number | K972969 |
| Device Name: | QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM |
| Classification | Tube, Collection, Capillary Blood |
| Applicant | INNOVATIVE MEDICAL TECHNOLOGIES, INC. 10661 RENE ST. Lenexa, KS 66215 |
| Contact | Bradley V Brown |
| Correspondent | Bradley V Brown INNOVATIVE MEDICAL TECHNOLOGIES, INC. 10661 RENE ST. Lenexa, KS 66215 |
| Product Code | GIO |
| CFR Regulation Number | 864.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-11 |
| Decision Date | 1997-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857182006104 | K972969 | 000 |
| 50857182006093 | K972969 | 000 |
| 30857182006075 | K972969 | 000 |