The following data is part of a premarket notification filed by Palmetto Chemical & Supply Co., Inc. with the FDA for Weck Instrument Cleaner, Cat. No. 850-103.
Device ID | K861588 |
510k Number | K861588 |
Device Name: | WECK INSTRUMENT CLEANER, CAT. NO. 850-103 |
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 |