The following data is part of a premarket notification filed by Lake Medical Products, Inc. with the FDA for Lake Wound Care/treatment Kit.
Device ID | K873973 |
510k Number | K873973 |
Device Name: | LAKE WOUND CARE/TREATMENT KIT |
Classification | General Surgery Tray |
Applicant | LAKE MEDICAL PRODUCTS, INC. 11866 ADIE RD. Maryland Heights, MO 63043 |
Contact | Eli Schachet |
Correspondent | Eli Schachet LAKE MEDICAL PRODUCTS, INC. 11866 ADIE RD. Maryland Heights, MO 63043 |
Product Code | LRO |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-29 |
Decision Date | 1987-11-20 |