The following data is part of a premarket notification filed by Robert I. Chien & Assoc., Inc. with the FDA for Surgical Instruments.
| Device ID | K801819 |
| 510k Number | K801819 |
| Device Name: | SURGICAL INSTRUMENTS |
| Classification | Clamp |
| Applicant | ROBERT I. CHIEN & ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HXD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-31 |
| Decision Date | 1980-08-20 |