The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Bowl, Sponge, Disposable, Sterile & Non-sterile.
Device ID | K874186 |
510k Number | K874186 |
Device Name: | BOWL, SPONGE, DISPOSABLE, STERILE & NON-STERILE |
Classification | 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la |
Applicant | BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 11067 Hauppauge, NY 11788 |
Contact | Partha Basumallik |
Correspondent | Partha Basumallik BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 11067 Hauppauge, NY 11788 |
Product Code | LDQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-14 |
Decision Date | 1987-12-29 |