The following data is part of a premarket notification filed by Nanma Mfg Co., Ltd. with the FDA for Nanma Vacuum Pump.
Device ID | K993909 |
510k Number | K993909 |
Device Name: | NANMA VACUUM PUMP |
Classification | Device, External Penile Rigidity |
Applicant | NANMA MFG CO., LTD. P.O. BOX 4341 Crofton, MD 21114 |
Contact | E.j. Smith |
Correspondent | E.j. 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 | 1999-11-17 |
Decision Date | 2000-07-19 |