The following data is part of a premarket notification filed by Far East Intl. Trading Corp. with the FDA for Surgical Blade.
| Device ID | K881638 |
| 510k Number | K881638 |
| Device Name: | SURGICAL BLADE |
| Classification | Blade, Scalpel |
| Applicant | FAR EAST INTL. TRADING CORP. 727 N. BROADWAY, SUITE 101 Los Angeles, CA 90012 |
| Contact | Julia Sun |
| Correspondent | Julia Sun FAR EAST INTL. TRADING CORP. 727 N. BROADWAY, SUITE 101 Los Angeles, CA 90012 |
| Product Code | GES |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-14 |
| Decision Date | 1988-06-15 |