FDA Registration
Active
🇺🇸 United States
SUMMERS LABORATORIES INC.
Reg #: 1000121375
·
FEI: 1000121375
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SUMMERS LABORATORIES INC.
- Registration Number
- 1000121375
- FEI Number
- 1000121375
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 103 GP Clement Drive
- City
- Collegeville
- State
- PA
- ZIP
- 19426
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113693
Owner / Operator
- Firm Name
- Summers Laboratories Inc.
- Operator Number
- 10090292
- Address
- 103 GP Clement Drive
- City
- Collegeville
- State
- PA
- Postal Code
- 19426
- Country
- US
- Correspondent
- Linda Czeiner
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2024-03-08 |
Proprietary Names
HypoCyn
Establishment Types
Repack or Relabel Medical Device