The following data is part of a premarket notification filed by Supelco, Inc. with the FDA for Gas-chromatographic Packing.
Device ID | K801833 |
510k Number | K801833 |
Device Name: | GAS-CHROMATOGRAPHIC PACKING |
Classification | Column Supports, Glc |
Applicant | SUPELCO, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DJA |
CFR Regulation Number | 862.2250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-08-01 |
Decision Date | 1980-08-27 |