FDA Registration
Active
🇺🇸 United States
Summit Packaging Solutions LLC
Reg #: 3012117640
·
FEI: 3012117640
·
Expires 2026
Products
15
Proprietary Names
15
Establishment Types
1
Classifications
15
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Registration Details
- Registration Name
- Summit Packaging Solutions LLC
- Registration Number
- 3012117640
- FEI Number
- 3012117640
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 950 Logistics Parkway
- City
- Jackson
- State
- GA
- ZIP
- 30233
- Country
- US
Regulatory Submissions
- 510(k) Number
- K061199
Owner / Operator
- Firm Name
- Summit Packaging Solutions LLC
- Operator Number
- 10051178
- Address
- 2481 Wright Blvd
- City
- Hebron
- State
- KY
- Postal Code
- 41048
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2016-12-28 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2016-12-28 |
| Tampon, Menstrual, Unscented | HEB | Class 2 | Obstetrics/Gynecology | No | 2016-12-28 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2016-12-28 |
| Tip, Rubber, Oral Hygiene | JEW | Class 1 | Dental | No | 2016-12-28 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2016-12-28 |
| Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt | KOO | Class 1 | Dental | No | 2016-12-28 |
| Scraper, Tongue | LCN | Class 1 | Dental | No | 2016-12-28 |
| Tampon, Menstrual, Scented, Scented-Deodorized | HIL | Class 2 | Obstetrics/Gynecology | No | 2016-12-28 |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | NRC | Class 1 | Obstetrics/Gynecology | No | 2016-12-28 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2016-12-28 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2016-02-12 |
| Dental Hygiene Kit | NXZ | Class 1 | Dental | No | 2016-12-28 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2016-12-28 |
| Floss, Dental | JES | Class 1 | Dental | No | 2016-12-28 |
Proprietary Names
Incontience Protective Garment
Powered Toothbrush
Unscented Menstrual Tampon
Massaging Pick
Oral Hygiene Rubber Tip
Over The Counter Denture Cleanser
Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt- Adhesive, Denture
Tongue Scraper
Deodorized Scented Menstrual Tampon
Deodorized Scented Menstrual Pad
cavity Varnish
Toothbrush
Dental Hygiene Kit
Unscented Menstrual Pad
Dental Floss
Establishment Types
Repack or Relabel Medical Device