The following data is part of a premarket notification filed by Mac Lee Medical Products with the FDA for Disposable Barium Enema Tip With Retention Cuff.
| Device ID | K872006 |
| 510k Number | K872006 |
| Device Name: | DISPOSABLE BARIUM ENEMA TIP WITH RETENTION CUFF |
| Classification | Catheter, Retention, Barium Enema With Bag |
| 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 | FGD |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-26 |
| Decision Date | 1987-11-17 |