The following data is part of a premarket notification filed by Surgimark, Inc. with the FDA for Ultravac-ng(tm) Nasogastric Sump Suction Tube.
Device ID | K926073 |
510k Number | K926073 |
Device Name: | ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE |
Classification | Tube, Double Lumen For Intestinal Decompression And/or Intubation |
Applicant | SURGIMARK, INC. 4706 WEST NOB HILL BLVD. Yakima, WA 98908 |
Contact | Richard J Yarger |
Correspondent | Richard J Yarger SURGIMARK, INC. 4706 WEST NOB HILL BLVD. Yakima, WA 98908 |
Product Code | FEG |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-01 |
Decision Date | 1995-05-15 |