The following data is part of a premarket notification filed by Alto Development Corp. with the FDA for A & E Medical Electrocautery Suction Tube With Finger Tip Activator Button.
| Device ID | K964621 |
| 510k Number | K964621 |
| Device Name: | A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ALTO DEVELOPMENT CORP. 5206 ASBURY RD. Farmingdale, NJ 07727 |
| Contact | Michael T Wojciechowicz |
| Correspondent | Michael T Wojciechowicz ALTO DEVELOPMENT CORP. 5206 ASBURY RD. 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 | 1996-11-18 |
| Decision Date | 1996-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20841291105043 | K964621 | 000 |
| 20841291105012 | K964621 | 000 |
| 20841291104985 | K964621 | 000 |