The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Macro Suction Tube Model No 10061.
| Device ID | K950754 |
| 510k Number | K950754 |
| Device Name: | MACRO SUCTION TUBE MODEL NO 10061 |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids, MI 49501 |
| Contact | Marjorie Bush |
| Correspondent | Marjorie Bush DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids, MI 49501 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-17 |
| Decision Date | 1995-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994570486 | K950754 | 000 |
| 20613994570462 | K950754 | 000 |