The following data is part of a premarket notification filed by Palmetto Chemical & Supply Co., Inc. with the FDA for Wec-kleen, Catalog N. 850-102.
| Device ID | K861590 |
| 510k Number | K861590 |
| Device Name: | WEC-KLEEN, CATALOG N. 850-102 |
| Classification | Cleaner, Ultrasonic, Medical Instrument |
| Applicant | PALMETTO CHEMICAL & SUPPLY CO., INC. 600 STITT ST. P.O. BOX 1218 Monroe, NC 28110 |
| Contact | D. F Aderholdt |
| Correspondent | D. F Aderholdt PALMETTO CHEMICAL & SUPPLY CO., INC. 600 STITT ST. P.O. BOX 1218 Monroe, NC 28110 |
| Product Code | FLG |
| CFR Regulation Number | 880.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-29 |
| Decision Date | 1986-06-17 |