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 |