The following data is part of a premarket notification filed by T.c. Dental Products, Inc. with the FDA for Starryshine Gauze Sponge.
| Device ID | K983450 |
| 510k Number | K983450 |
| Device Name: | STARRYSHINE GAUZE SPONGE |
| Classification | Gauze/sponge, Internal |
| Applicant | T.C. DENTAL PRODUCTS, INC. 20957 CURRIER RD., #E Walnut, CA 91789 |
| Contact | Jen Wang |
| Correspondent | Jen Wang T.C. DENTAL PRODUCTS, INC. 20957 CURRIER RD., #E Walnut, CA 91789 |
| Product Code | EFQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-30 |
| Decision Date | 1998-11-12 |
| Summary: | summary |