The following data is part of a premarket notification filed by Kencap Ltd. with the FDA for Instruments For One Time Use - Disposable.
| Device ID | K011514 |
| 510k Number | K011514 |
| Device Name: | INSTRUMENTS FOR ONE TIME USE - DISPOSABLE |
| Classification | Kit, Surgical Instrument, Disposable |
| Applicant | KENCAP LTD. 247 MARGARET KING AVE. Ringwood, NJ 07456 |
| Contact | Marty Delin |
| Correspondent | Marty Delin KENCAP LTD. 247 MARGARET KING AVE. Ringwood, NJ 07456 |
| Product Code | KDD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-17 |
| Decision Date | 2001-08-13 |