FDA Registration
Active
🇺🇸 United States
Summit Packaging Solutions LLC
Reg #: 3012118920
·
FEI: 3012118920
·
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
- 3012118920
- FEI Number
- 3012118920
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9300 Olde Scotland Rd
- City
- Shippensburg
- State
- PA
- ZIP
- 17257
- Country
- US
Regulatory Submissions
- 510(k) Number
- K131543
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 |
|---|---|---|---|---|---|
| Tampon, Menstrual, Unscented | HEB | Class 2 | Obstetrics/Gynecology | No | 2016-12-28 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2016-12-28 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2016-12-28 |
| Garment, Protective, For Incontinence | EYQ | Class 1 | Gastroenterology, Urology | No | 2016-12-28 |
| Tip, Rubber, Oral Hygiene | JEW | Class 1 | Dental | 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 |
| Dental Hygiene Kit | NXZ | Class 1 | Dental | No | 2016-12-28 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2016-12-28 |
| Tampon, Menstrual, Scented, Scented-Deodorized | HIL | Class 2 | Obstetrics/Gynecology | No | 2016-12-28 |
| Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt | KOO | Class 1 | Dental | No | 2016-12-28 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2016-12-28 |
| Floss, Dental | JES | Class 1 | Dental | No | 2016-12-28 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2016-12-28 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2016-02-12 |
| Scraper, Tongue | LCN | Class 1 | Dental | No | 2016-12-28 |
Proprietary Names
Unscented Menstrual Tampon
Powered Toothbrush
Unscented Menstrual Pad
Incontience Protective Garment
Oral Hygiene Rubber Tip
Deodorized Scented Menstrual Pad
Dental Hygiene Kit
Massaging Pick
Deodorized Scented Menstrual Tampon
Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt- Adhesive, Denture
Over The Counter Denture Cleanser
Dental Floss
cavity Varnish
Toothbrush
Tongue Scraper
Establishment Types
Repack or Relabel Medical Device