The following data is part of a premarket notification filed by Anago, Inc. with the FDA for Anago Isolation Mask (#80-950).
| Device ID | K864116 |
| 510k Number | K864116 |
| Device Name: | ANAGO ISOLATION MASK (#80-950) |
| Classification | Chamber, Patient Isolation |
| Applicant | ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
| Contact | Kathy Russell |
| Correspondent | Kathy Russell ANAGO, INC. 7524 MOSIER VIEW CT. Fort Worth, TX 76118 |
| Product Code | LGM |
| CFR Regulation Number | 880.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-21 |
| Decision Date | 1986-11-25 |