FDA Registration
Active
🇺🇸 United States
PUMA-G System
Reg #: 3015177732
·
FEI: 3015177732
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- CoapTech, Inc.
- Registration Number
- 3015177732
- FEI Number
- 3015177732
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 101 W. Dickman Street, Suite 700
- City
- Baltimore
- State
- MD
- ZIP
- 21230
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223916
Owner / Operator
- Firm Name
- CoapTech
- Operator Number
- 10058608
- Address
- 101 W Dickman St, Suite 900
- City
- Baltimore
- State
- MD
- Postal Code
- 21230
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tube, Gastro-Enterostomy | KGC | Class 2 | Gastroenterology, Urology | No | 2024-02-22 |
Proprietary Names
PUMA-G System
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198