The following data is part of a premarket notification filed by Supelco, Inc. with the FDA for Capillary Columns For Gas Chromatography.
Device ID | K862542 |
510k Number | K862542 |
Device Name: | CAPILLARY COLUMNS FOR GAS CHROMATOGRAPHY |
Classification | Columns, Glc |
Applicant | SUPELCO, INC. SUPELCO PARK Bellefonte, PA 16823 -0048 |
Contact | Lloyd A Witting,phd |
Correspondent | Lloyd A Witting,phd SUPELCO, INC. SUPELCO PARK Bellefonte, PA 16823 -0048 |
Product Code | DII |
CFR Regulation Number | 862.2250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-03 |
Decision Date | 1986-08-04 |