The following data is part of a premarket notification filed by Moss Medical Products with the FDA for Mossmed Dual Intermittent Aspirator.
Device ID | K031492 |
510k Number | K031492 |
Device Name: | MOSSMED DUAL INTERMITTENT ASPIRATOR |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | MOSS MEDICAL PRODUCTS 4049 NY 150 West Sand Lake, NY 12196 |
Contact | Gerald Moss |
Correspondent | Gerald Moss MOSS MEDICAL PRODUCTS 4049 NY 150 West Sand Lake, NY 12196 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-05-12 |
Decision Date | 2004-02-05 |
Summary: | summary |