The following data is part of a premarket notification filed by Nanma Mfg Co., Ltd. with the FDA for Nanma Adjustable Constriction Ring.
| Device ID | K013051 |
| 510k Number | K013051 |
| Device Name: | NANMA ADJUSTABLE CONSTRICTION RING |
| Classification | Device, External Penile Rigidity |
| Applicant | NANMA MFG CO., LTD. P.O. BOX 4341 Crofton, MD 21114 |
| Contact | Yolanda Smith |
| Correspondent | Yolanda Smith NANMA MFG CO., LTD. P.O. BOX 4341 Crofton, MD 21114 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-11 |
| Decision Date | 2002-08-22 |