510(k) K771732
- Device
- THORNTON ANTERIOR CHAMBER IRRIGATOR
- Applicant
- Concept, Inc.
- 510(k) number
- K771732
- Product code
- GBQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-09-28
- Date received
- 1977-09-15
- Regulation
- 878.4200
- Classification name
- Catheter, Continuous Irrigation
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3005841027
- 3010339057
- 1718873
- 1055236
- 3003965134
- 1625425
- 3003902757
- 3043349275
- 1644312
- 3035678069
- 9610694
- 3006538822
- 3021284283
- 3010656982
- 3010131137
- 1043214
- 3003814961
- 3004111573
- 1423537
- 9616088
- 1417485
- 2320762
- 9611503
- 1054241
- 1034876
- 3010583458
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GBQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K941356 | MICROFLOW IRRIGATION SYSTEM | Jedmed Instrument Co. | 1994-05-19 |
| K921464 | CAT.#40100, 40102, 40104 & 40106 YANKAUER SUCT INT | Trinity Laboratories, Inc. | 1992-05-05 |
| K882647 | GESCO CATHETERIZATION TRAY | Gesco Intl., Inc. | 1988-09-09 |
| K874596 | PERFORATED SOAKING TUBE | Specialty Medical Products Co. | 1987-12-02 |
| K873097 | PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS | Ipax, Inc. | 1987-09-04 |
| K872787 | MODIFIED CURLCATH | Quinton, Inc. | 1987-08-04 |
| K791400 | GASTRIC LAVAGE KIT-DISPOSABLE | Acumed Instruments Corp. | 1979-08-16 |