510(k) K013053 ยท LKY Device, External Penile Rigidity
MODIFICATION TO NANMA NON-ADJUSTABLE CONSTRICTION RING
| Applicant | Nanma Mfg Co., Ltd., Crofton MD, US |
| Decision | Substantially Equivalent, May 9, 2002 |
| Received | Sep 11, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013053
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.