The following data is part of a premarket notification filed by Holtsch Co., Inc. with the FDA for Quickpad (alcohol Swabs).
Device ID | K892193 |
510k Number | K892193 |
Device Name: | QUICKPAD (ALCOHOL SWABS) |
Classification | Pad, Alcohol, Device Disinfectant |
Applicant | HOLTSCH CO., INC. RURAL ROUTE 3 BOX 94 Califon, NJ 07830 |
Contact | C Scheytt |
Correspondent | C Scheytt HOLTSCH CO., INC. RURAL ROUTE 3 BOX 94 Califon, NJ 07830 |
Product Code | LKB |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-05 |
Decision Date | 1989-08-04 |