The following data is part of a premarket notification filed by Automated Medical Products Corp. with the FDA for Deep Suture.
| Device ID | K942818 |
| 510k Number | K942818 |
| Device Name: | DEEP SUTURE |
| Classification | Instrument, Manual, Surgical, General Use |
| Applicant | AUTOMATED MEDICAL PRODUCTS CORP. 2315 BROADWAY, SUITE 410 New York, NY 10024 |
| Contact | Gregory Diamant |
| Correspondent | Gregory Diamant AUTOMATED MEDICAL PRODUCTS CORP. 2315 BROADWAY, SUITE 410 New York, NY 10024 |
| Product Code | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-15 |
| Decision Date | 1994-08-25 |