The following data is part of a premarket notification filed by Biological & Environmental Control Laboratories with the FDA for Shave Prep Kits.
| Device ID | K842989 |
| 510k Number | K842989 |
| Device Name: | SHAVE PREP KITS |
| Classification | Bedding, Disposable, Medical |
| Applicant | BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES 615 FRONT ST. Toledo, OH 43605 |
| Contact | James P Kulla |
| Correspondent | James P Kulla BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES 615 FRONT ST. Toledo, OH 43605 |
| Product Code | KME |
| CFR Regulation Number | 880.6060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-30 |
| Decision Date | 1984-12-04 |