The following data is part of a premarket notification filed by Wave Energy Systems, Inc. with the FDA for Wavicide(r) -01.
| Device ID | K914749 |
| 510k Number | K914749 |
| Device Name: | WAVICIDE(R) -01 |
| Classification | Sterilant, Medical Devices |
| Applicant | WAVE ENERGY SYSTEMS, INC. 218 LITTLE FALLS RD. Cedar Grove, NJ 07009 |
| Contact | Penny Stagliano |
| Correspondent | Penny Stagliano WAVE ENERGY SYSTEMS, INC. 218 LITTLE FALLS RD. Cedar Grove, NJ 07009 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-22 |
| Decision Date | 1995-08-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H65810446811 | K914749 | 000 |
| 20302730000027 | K914749 | 000 |
| 20302730002335 | K914749 | 000 |