The following data is part of a premarket notification filed by Artiberia with the FDA for 7-120, 7-130,7-140, 7-150,9-151 To 168, 9-171 To 1.
Device ID | K851751 |
510k Number | K851751 |
Device Name: | 7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1 |
Classification | Scalpel, One-piece |
Applicant | ARTIBERIA 4518 LOS RANCHITOS San Antonio, TX 78233 |
Contact | Gil M Sanchez |
Correspondent | Gil M Sanchez ARTIBERIA 4518 LOS RANCHITOS San Antonio, TX 78233 |
Product Code | GDX |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-25 |
Decision Date | 1985-06-20 |