The following data is part of a premarket notification filed by Mac Lee Medical Products with the FDA for Scalp Vein Set.
| Device ID | K870995 |
| 510k Number | K870995 |
| Device Name: | SCALP VEIN SET |
| Classification | Set, Administration, Intravascular |
| Applicant | MAC LEE MEDICAL PRODUCTS 2900 S.W. ATWOOD Topeka, KS 66614 |
| Contact | George E Liesmann |
| Correspondent | George E Liesmann MAC LEE MEDICAL PRODUCTS 2900 S.W. ATWOOD Topeka, KS 66614 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-11 |
| Decision Date | 1987-07-31 |