The following data is part of a premarket notification filed by Kleen Test Products with the FDA for Elastic Style Impervious Orthopedic Stockinet.
| Device ID | K844199 |
| 510k Number | K844199 |
| Device Name: | ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET |
| Classification | Drape, Surgical |
| Applicant | KLEEN TEST PRODUCTS 4425 W. WOOLWORTH AVE. P.O.B OX 574 Milwaukee, WI 53218 |
| Contact | Rick W Poenitsch |
| Correspondent | Rick W Poenitsch KLEEN TEST PRODUCTS 4425 W. WOOLWORTH AVE. P.O.B OX 574 Milwaukee, WI 53218 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-30 |
| Decision Date | 1984-11-07 |