The following data is part of a premarket notification filed by Syntex Corp. with the FDA for Surgipress Surgical Loop.
| Device ID | K843593 |
| 510k Number | K843593 |
| Device Name: | SURGIPRESS SURGICAL LOOP |
| Classification | Hemostat |
| Applicant | SYNTEX CORP. 3401 HILLVIEW AVE. Palo Alto, CA 94304 |
| Contact | Jean Strand |
| Correspondent | Jean Strand SYNTEX CORP. 3401 HILLVIEW AVE. Palo Alto, CA 94304 |
| Product Code | HRQ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-12 |
| Decision Date | 1984-10-24 |