Holopack International, LP is one of 7084 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Holopack International, LP - FDA 510(k) Cleared Devices
Recent clearances: 0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP, SODIUM CHLORIDE INHALATION SOLUTION, USP, STERILE WATER FOR INHALATION, USP
3
Total
3
Cleared
0
Denied
Holopack International, LP, is a pharmaceutical manufacturer with a registered facility in Columbia, US. The company specializes in sterile inhalation solutions and related pharmaceutical products.
Holopack received 3 FDA 510(k) clearances from 3 total submissions, with no denied submissions on record. The company's regulatory focus centered on Anesthesiology devices, representing 100% of its submission activity. Clearances were granted between 1997 and 1998.
The company is inactive and should be treated as a historical regulatory record. No FDA 510(k) clearances have been issued since 1998. Historical cleared products included sodium chloride inhalation solutions and sterile water for inhalation, USP.
Explore the complete regulatory history, including device names, product codes, and clearance dates in the FDA 510(k) database.
FDA 510(k) Regulatory Record - Holopack International, LP
3 devices