The following data is part of a premarket notification filed by Prestige Medical Corp. with the FDA for Prestige Medical Series 2100 Clinical Autoclave.
| Device ID | K962903 |
| 510k Number | K962903 |
| Device Name: | PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE |
| Classification | Sterilizer, Steam |
| Applicant | PRESTIGE MEDICAL CORP. 1455 PENNSYLVANIA AVE., N.W. Washington, DC 20004 |
| Contact | Mark A Heller |
| Correspondent | Mark A Heller PRESTIGE MEDICAL CORP. 1455 PENNSYLVANIA AVE., N.W. Washington, DC 20004 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-25 |
| Decision Date | 1998-03-03 |
| Summary: | summary |