510(k) K942810
- Device
- PALCO LABS COLD POUCH
- Applicant
- PALCO LABORATORIES, INC.
- 510(k) number
- K942810
- Product code
- LDQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-06-28
- Date received
- 1994-06-15
- Regulation
- 510(k) Premarket Notification
- Classification name
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- EDWARD CALCARCEL
- Address
- 8030 Soquel Ave., #104 Santa Cruz CA US 95062 95062
FDA Registration Numbers#
- 9616088
- 3004167615
- 1061124
- 3008061617
- 1125615
- 3004111573
- 9611024
- 9612030
- 1423537
- 9610849
Source Documents#
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases