The following data is part of a premarket notification filed by Endoscopic Technologies, Inc. with the FDA for Tubing, Noninvasive.
| Device ID | K945978 |
| 510k Number | K945978 |
| Device Name: | TUBING, NONINVASIVE |
| Classification | Tubing, Noninvasive |
| Applicant | ENDOSCOPIC TECHNOLOGIES, INC. 6550A BEST FRIEND RD. Nordcross, GA 30071 |
| Contact | Freddie P Andrieni |
| Correspondent | Freddie P Andrieni ENDOSCOPIC TECHNOLOGIES, INC. 6550A BEST FRIEND RD. Nordcross, GA 30071 |
| Product Code | GAZ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-08 |
| Decision Date | 1995-01-11 |