The following data is part of a premarket notification filed by Albert Browne Ltd. with the FDA for Albert Browne Ltd. Verify Steam Value Indicators.
| Device ID | K060103 |
| 510k Number | K060103 |
| Device Name: | ALBERT BROWNE LTD. VERIFY STEAM VALUE INDICATORS |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | ALBERT BROWNE LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J.m. Nolte |
| Correspondent | Cynthia J.m. Nolte ALBERT BROWNE LTD. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-13 |
| Decision Date | 2006-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H816TSI4401 | K060103 | 000 |
| H816MTSI4402 | K060103 | 000 |