The following data is part of a premarket notification filed by Alto Development Corp. with the FDA for Electro-cautery Suction Tube.
| Device ID | K881413 |
| 510k Number | K881413 |
| Device Name: | ELECTRO-CAUTERY SUCTION TUBE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ALTO DEVELOPMENT CORP. 5012 ASBURY RD. P.O. BOX 758 Farmingdale, NJ 07727 |
| Contact | Alex Wojciechowicz |
| Correspondent | Alex Wojciechowicz ALTO DEVELOPMENT CORP. 5012 ASBURY RD. P.O. BOX 758 Farmingdale, NJ 07727 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-04 |
| Decision Date | 1988-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04026704532148 | K881413 | 000 |
| 24026704532128 | K881413 | 000 |
| 24026704532135 | K881413 | 000 |
| 24026704532142 | K881413 | 000 |
| 24026704662153 | K881413 | 000 |
| 20841291104879 | K881413 | 000 |
| 20841291104909 | K881413 | 000 |
| 20841291104930 | K881413 | 000 |
| 04026704400270 | K881413 | 000 |
| 04026704532131 | K881413 | 000 |
| 24026704662146 | K881413 | 000 |