The following data is part of a premarket notification filed by Schuco, Inc. with the FDA for Schuco-vac Model 178.
| Device ID | K935218 |
| 510k Number | K935218 |
| Device Name: | SCHUCO-VAC MODEL 178 |
| Classification | Apparatus, Suction, Ward Use, Portable, Ac-powered |
| Applicant | SCHUCO, INC. SUITE 500 3000 K STREET N.W. Washington, DC 20007 -5109 |
| Contact | Ilene Knable Gotts |
| Correspondent | Ilene Knable Gotts SCHUCO, INC. SUITE 500 3000 K STREET N.W. Washington, DC 20007 -5109 |
| Product Code | JCX |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-26 |
| Decision Date | 1994-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00260720011414 | K935218 | 000 |
| 00026072011300 | K935218 | 000 |
| 00026072011317 | K935218 | 000 |
| 00026072011324 | K935218 | 000 |
| 00026072011393 | K935218 | 000 |
| 00026072011409 | K935218 | 000 |
| 00026072011416 | K935218 | 000 |
| 00260720011292 | K935218 | 000 |
| 00260720011308 | K935218 | 000 |
| 00260720011315 | K935218 | 000 |
| 00260720011322 | K935218 | 000 |
| 00260720011391 | K935218 | 000 |
| 00260720011407 | K935218 | 000 |
| 00026072011294 | K935218 | 000 |