510(k) K831340
- Device
- Drain-r-drape(eye
- Applicant
- SUR-TECH, INC.
- 510(k) number
- K831340
- Product code
- HMT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-06-08
- Date received
- 1983-04-25
- Regulation
- 878.4370
- Classification name
- Drape, Patient, Ophthalmic
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3009750712
- 3038896637
- 1055236
- 3014925393
- 3009600453
- 1610287
- 3017636737
- 3013401749
- 3010487482
- 3017364709
- 3010807315
- 1061124
- 3005391805
- 8043817
- 1928237
- 3007344957
- 3033526648
- 1644019
- 1053428
- 3030645716
- 3003951061
- 3004513970
- 1226074
- 3042228518
- 3004911384
- 3006550126
- 1043214
- 3017461134
- 3004111573
- 3008352964
- 1650907
- 1423537
- 9616088
- 1054069
- 3014255036
- 9614277
- 3015633688
- 3016970619
- 3017194442
- 1054241
- 3016874083
- 3021970868
- 3005012805
- 1043549
- 1921846
- 1721686
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HMT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K945738 | VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE | Visitec Co. | 1995-02-14 |
| K905460 | STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY | Angiosystems, Inc. | 1991-02-06 |
| K872620 | SOLOS EYESITE DRAPES | Solos Ophthalmology | 1987-07-31 |
| K871706 | OPTHA PREP | Treace Medical, Inc. | 1987-05-18 |
| K854613 | SURGICAL DRAPES, OPHTHALMIN | Charles Atkins & Co. | 1986-02-13 |
| K830822 | EYE DRAPE | CooperVision, Inc. | 1983-04-06 |